Patient Safety and Pharmacovigilance Intern Job at Kailera Therapeutics (Waltham)

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Manager, Patient Safety and Pharmacovigilance Operations

Reporting to the Senior Director, Patient Safety and Pharmacovigilance (PSPV) Op...

Location

United States , Waltham

Salary:

110000.00 - 140000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Minimum of 6+ years of experience in Drug Safety/Pharmacovigilance Operations within the pharmaceutical or biotechnology industry
Working knowledge of global PV regulations, including FDA and ICH guidelines
Demonstrated working knowledge of safety databases (e.g., Argus), especially reports generation, PV dashboard, etc
Demonstrated ability to work collaboratively in a fast-paced, cross-functional, and matrixed environment with strong organizational, time management, and project prioritization skills. Excellent verbal and written communication and interpersonal skills
Prior PV Operations and safety vendor management experience required
Adaptable to changing priorities
Proficient computer skills, including Microsoft Word and Excel
Must be able and willing to travel on occasion
Bachelor’s degree in Life Sciences (or equivalent experience) or a related field required. (BS, RN, preferred)

Job Responsibility

Act as a subject matter expert on emerging global guidelines and regulations, assessing impact on existing procedures, and recommending updates
Support PSPV Operations in the development and maintenance of safety vendor documentation (e.g., SMP, SAE/AESI, Pregnancy Reporting forms, etc.)
Responsible for the oversight of the safety vendor ICSR case processing and reporting activities (e.g., ensuring high quality and compliant case processing and submission activities including narrative writing, coding (MedDRA), query resolution, reports generation, study closure, etc.), SAE Reconciliation support, and safety vendor metrics (e.g., KPIs and KQIs, etc.) as defined in the SMP
Act as primary day-to-day liaison with the safety vendor project manager and team leads to ensure efficient case workflow to meet PSPV and alliance partner obligations
Support in-line and/or retrospective case quality review (e.g., to assess coding accuracy, narrative completeness, data integrity, regulatory compliance, etc.)
Develop and maintain a robust and easily navigable PSPV SharePoint repository
Document, track, and escalate issues or quality trends as per process and the PV Quality Agreement. Identify process or quality gaps and contribute to effective, stage appropriate, and compliant solutions
Collaborate with the safety vendor to provide timely delivery of internal and external safety database data extract requests and support safety database activities (e.g., database updates, processes, new study configurations, access issue escalations, case processing conventions, system implementation/transitions, etc.)
Contribute to controlled document development and maintenance (e.g., SOPs, WIs, SAE/pregnancy forms, SMPs, etc.) and support inspection readiness activities
Support PSPV Aggregate reporting activities (e.g., signal detection, DSUR, risk management, literature review, etc.), as required

What we offer

comprehensive health coverage
flexible time off
paid holidays
a year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Patient Safety Associate II/Patient Safety Specialist - Japanese

Patient Safety Associate II/Patient Safety Specialist - Japanese role at Parexel...

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Sound knowledge of drug safety and the drug development process
Knowledge of and ability to interpret and apply global safety regulations
Experience in data analysis and evaluation of safety data
Good presentation skills
Analytical and problem-solving skills
Clear understanding of the regulatory submission process
Proficient in database/literature searches
Excellent interpersonal skills
Excellent verbal / written communication skills
Excellent organizational and prioritization skills

Job Responsibility

Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
Assist in development of project specific safety procedures, workflows and templates
Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
Delegate work as appropriate to Drug Safety Assistants
Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
Mentoring new recruits in the team, if required
Archiving the source documents and relevant emails as required

Senior Manager, Patient Safety and Pharmacovigilance Quality

Reporting to the Senior Director, Patient Safety and Pharmacovigilance (PSPV) Op...

Location

United States , Waltham

Salary:

136000.00 - 170000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

Minimum of 8+ years of experience in Drug Safety/Pharmacovigilance (specifically, PV quality and compliance, and/or operations) within the pharmaceutical or biotechnology industry
Knowledge of global safety and PV regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP, GxP)
Demonstrated experience in audits/inspections, quality investigations, or CAPA management
Proven ability to identify issues, analyze root causes, propose, and implement effective solutions
Strong organizational, time management, and project prioritization skills, including excellent verbal and written communication and interpersonal skills, and proficient computer skills, including Microsoft Word and Excel
Demonstrated ability to work collaboratively in a fast-paced, cross-functional, and matrixed environment, and adaptable to changing priorities
Must be able and willing to travel on occasion
Bachelor’s degree in Life Sciences (or equivalent experience) or a related field required. (BS, RN, preferred)

Job Responsibility

Monitor global regulatory requirements, procedures, and guidance (e.g., ICH, FDA, EMA, MHRA, TGA, and ICH-GCP/ICH-E2E guidelines, etc.) and assess impact on existing procedures and recommending updates
Develop and maintain quality metrics for PSPV operations (e.g., SAE case reconciliation, inline and retrospective ICSR review, etc.)
Identify process gaps and develop stage-appropriate solutions within PSPV and the safety vendor
Support the development and maintenance of PSPV departmental Key Performance Indicators (KPI), Key Quality Indicators (KQIs), and monthly compliance metrics
Develop and implement processes for the management of all PSPV procedures and controlled documents (e.g., Policies, SOPs, WIs)
Track PV deviations, compliance issues, or other quality events
Contribute to CAPA development, review, monitor, and trend root cause analyses and propose preventive actions
Partner with Quality Assurance and other key stakeholders and provide PSPV input into organizational initiatives (e.g. quality monitoring, system implementations/improvements, process changes, inspection readiness)
Contribute to the maintenance of PSPV Pharmacovigilance Agreements
Support PSPV document review activities (e.g., signal detection, DSUR, risk management plans, literature review, etc.)

What we offer

comprehensive health coverage
flexible time off
paid holidays
year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Executive Director, Medicine Development Leader

GSK is seeking a highly skilled Executive Director, Medicine Development Leader ...

Location

United States; United Kingdom , Waltham; London; Stevenage; Collegeville

Salary:

242250.00 - 403750.00 USD / Year

GSK

Expiration Date

Until further notice

Requirements

Advanced degree including MD, PhD, PharmD, MBA, MS
Drug development expertise in the global pharmaceutical/biotechnology industry
Filing experience with BLA/NDA/MAA submissions as a core responsibility
Experience in the entirety of drug development across the R&D/commercial life cycle including Discovery, late-stage Development, Regulatory, Manufacturing Medical and Commercial
Experience in product development and/or commercialization, in late phase development (from clinical PoC onwards), clinical trial management, post-approval studies, regulatory and manufacturing compliance
Experience leading teams in a complex, matrixed, global and multi-disciplinary organization with high accountability, minimal authority and multiple lines of reporting
Experience working with regulators and with regulatory requirements including legal and government frameworks within and across global geographies
Experience creating the strategy for pre- and post-marketing studies and driving the lifecycle process
Experience building budgets and leading the strategic and budget planning process
Experience the healthcare environment, and access in all major markets

Job Responsibility

Act as a single point of accountability in GSK for all aspects of a medicine being developed globally, from proof of clinical activity (POC) to Approval in all major market(s)
Work closely with the Early Development Lead (EDL) and Medicine Commercial Lead (MCL) to ensure a smooth transition of the lead indication(s) from the EDL upon achievement of clinical PoC and to the MCL upon Approval in first major market(s)
Post-approval, provide key support to the Medicine Commercial Team (MCT) in the first major markets ensuring the MDT provides optimal support to registration, including Post-Marketing Requirements (PMRs) and life cycle management (LCM) in the major markets
Work with the functional line Heads supporting RIIRU to select MDT members and lead this multi-disciplinary matrix team, supporting differentiated development for team members, owning the performance of the MDT and partnering with Line Managers to drive performance
Partner with the Pipeline Project Manager (PPM), energize and motivate the MDT to drive a high performing team and operational delivery of the project, including setting team objectives to ensure successful project delivery, including options for acceleration, parallel indication development and smart risk-taking.
Partner with R&D Business Development, leading the development planning for a prospective in-licensed asset by bringing together input from the relevant functions and TA experts to develop a Medicine Profile (MP) and development plans including but not limited to clinical feasibility, regulatory planning and CMC risk mitigation
Leads the cross-functional MDT to: Establish a compelling vision for the medicine and Target Medicine Profile (TMP) which positions the medicine within the R&D strategy taking the competitive landscape into account, translating GSK’s strategy into asset strategy and actionable plans for multiple areas or functions
Deliver differentiated medicines of value for patients, stakeholders and markets through an evidence package that supports regulatory approval, market access and the product’s life cycle
Prioritize and maximize the asset’s development options including developing multiple indications
Partner with the Global Medical Lead (GML) and MCL to develop an indication expansion and LCM plan for the asset.

What we offer

Annual bonus
Eligibility to participate in our share based long term incentive program
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave

Fulltime

Senior Pharmacovigilance Associate

We are currently seeking a Senior Pharmacovigilance Associate to join our divers...

Location

Brazil , Sao Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, pharmacy, nursing, or a related field
High level of English proficiency
Based on Brazil - 100% remote position
Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards
Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection
Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations
Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams
Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite
Ability to work independently and manage multiple priorities in a fast-paced environment
Commitment to maintaining confidentiality and handling sensitive patient information with discretion

Job Responsibility

Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies
Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation
Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations
Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities
Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards
Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices
Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements
Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Clinical Study Physician - Oncology - FSP

Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is ...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Physician MD, ideally with medical thesis, trained in a clinical setting
Minimum of 4 years of active clinical experience
specialization in internal medicine or general practice preferred
Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development
Understanding of relevant regulations and guidance including ICH-GCP
Experienced with data visualization systems and IT systems
Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
Proficiency in written and spoken English and (local language)
Excellent interpersonal, active listening and influencing skills
Pronounced analytical skills and systematic and well-structured working style

Job Responsibility

Trial Start-Up: Responsible for medical content of Clinical Trial Protocols (CTPs)
Contribution to trial risk-based quality management from medical perspective
Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP)
Responsible for providing medical input into the definition of important protocol deviations (iPD)
Contribution to the timely preparation of medically relevant core trial documents and timely milestones
Medical input into Data Management documentation for the trial
Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan
Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs
Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans

What we offer

Flexible approach to work that meets your personal needs while maintaining quality delivery for patients
Choose the right work arrangement for you - in-office, home-based or a mix
Benefits vary by country, but Parexel is passionate about our team’s overall wellness
Investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career

Fulltime

Clinical Study Physician - Oncology

Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is ...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Physician MD, ideally with medical thesis, trained in a clinical setting
Minimum of 4 years of active clinical experience
specialization in internal medicine or general practice preferred
Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities
Understanding of relevant regulations and guidance including ICH-GCP
Experienced with data visualization systems and IT systems
Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
Proficiency in written and spoken English and (local language)
Excellent interpersonal, active listening and influencing skills
Pronounced analytical skills and systematic and well-structured working style

Job Responsibility

Trial Start-Up: Responsible for medical content of Clinical Trial Protocols (CTPs)
Contribution to trial risk-based quality management from medical perspective
Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP)
Responsible for providing medical input into the definition of important protocol deviations (iPD)
Contribution to the timely preparation of medically relevant core trial documents and timely milestones
Medical input into Data Management documentation for the trial
Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan
Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs
Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans

What we offer

Parexel offers a flexible approach to work that meets your personal needs while maintaining quality delivery for patients. Choose the right work arrangement for you - in-office, home-based or a mix
Benefits vary by country, but Parexel is passionate about our team’s overall wellness
We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career

Patient Safety and Pharmacovigilance Intern

Kailera Therapeutics

Location:
United States , Waltham

Category:
Pharmacy

Contract Type:
Employment contract

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 23, 2026

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