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

New

Project Lead, Patient Safety & Risk Management

Lead Excellence in Pharmacovigilance Delivery. Join our Patient Safety team as a...

Location

Australia , Melbourne, Sydney

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Degree in Pharmacy or a relevant scientific discipline (e.g. Pharmaceutical Sciences or Drug Development)
Minimum 3 years’ experience in patient safety or pharmacovigilance within a highly regulated environment (pharmaceuticals or medical devices)
Minimum 2 years of experience in project management
Experience in adverse event case processing, literature surveillance, and project or client management
Strong knowledge of regulatory requirements for adverse event reporting in Australia and New Zealand, with broader awareness of EU, Japan, and APAC requirements
Excellent communication, organisational, and problem‑solving skills, with proven ability to work independently and lead teams

Job Responsibility

Support cross-collaboration within the business by fostering relationships and collaborating with other business units to drive innovation, create efficiencies and expand service offering across the business
Provide high quality work that ensures client satisfaction and loyalty, leading to optimisation of repeat business and expansion of service provision
Responsible for client set up and contract management
Act as the Primary point of contact and Subject Matter Expert (SME), for the project
Monitor project progress, track agreed KPI’s and adjust plans as necessary to ensure project goals are met
Escalate inconsistencies/out of scope requirements to the Senior Manager
Prepare project reports to ensure project deliverables are met and activities performed by the project team are within the scope of the project
Assist with preparations for internal and external audits
Proactive contribution to improving business processes
Anticipate regulatory implications of emerging safety issues and offer clients strategies for handling/managing such issues

What we offer

Work with a diverse range of clients across medicines, vaccines, and medical devices, expanding your technical expertise and making a meaningful impact in Patient Safety across multiple therapeutic areas
Enjoy a flexible, hybrid work model and commitment to work-life balance
Join a company that values expertise, excellence, collaboration and continuous improvement

Fulltime

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

Manager, Drug Safety Physician, Pharmacovigilance Epidemiology & Risk Management

Location

India , Noida

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Degree in Medicine
Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety
Strong interpersonal and organizational skills
High sense of responsibility, dedication, and desire to work under pressure
Highly service oriented
Good communication skills
Fluent in English- spoken and written
Previous exposure to corporate environment, pharma and life sciences industry is an advantage
PG degree in any discipline is an advantage but not mandatory

Job Responsibility

Conduct Medical Review and assessment of ICSR’s into the safety database
Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment
Review and respond to any queries/comments from the case owner in the patient safety database
Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers
Maintain strong GPVP and GCP knowledge
Following ICH and EMA guidelines strongly and implementing them appropriately
Train and mentor PV associates on event capturing and general PV conventions as required
Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas
Escalate complex case issues on client products to Team Lead/Line Manager
Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature

Fulltime

Patient Safety Associate

Deliver Excellence in Pharmacovigilance. Join Our Patient Safety Team as a Patie...

Location

Australia , Melbourne, Sydney

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Health Science degree or equivalent
Minimum 3 years of experience in a drug safety or equivalent role in a highly regulated industry e.g., pharmaceutical or devices
Good working knowledge of the regulatory requirements for managing and reporting adverse events in Philippines
Experience in clinical trial pharmacovigilance
Understanding of the applicable Australia, New Zealand and EU requirements
Highly developed service, communication, organisational and problem-solving skills
High level of attention to detail and computer literacy with experience in safety database (Argus, ARISg, Veeva Safety)
Practical experience in SOP writing and document management

Job Responsibility

Act as part of PS & RM Team in line with the scope of the project to meet project outcomes and deliverables ensuring compliance
Work within the systems and processes designed to meet Good Pharmacovigilance Practices (GVP)
Ensure that all potential adverse events or product complaints associated with adverse events, are appropriately reported and followed up according to client procedures
Evaluate adverse events & follow up reports received from various channels and assesses seriousness based on criteria
Process & report safety data as per SOP and client instructions to maintain client and regulatory compliance
Maintain the integrity of client safety data registered into the safety databases
Participate in internal and external audits
Perform literature surveillance and regulatory authority adverse event searches
Assist the Project Manager or the Patient Safety Manager/ Senior Manager as requested (e.g. to provide input to SOPs or Safety Data Exchange Agreements)

What we offer

Work with a diverse range of clients across medicines, vaccines, and medical devices, expanding your technical expertise and making a meaningful impact in Patient Safety across multiple therapeutic areas
Enjoy a flexible, hybrid work model and commitment to work-life balance
Join a company that values expertise, excellence, collaboration and continuous improvement

Fulltime

Senior Patient Safety Specialist

Location

Philippines , Manila

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Expert knowledge of drug safety regulations and pharmacovigilance processes
Strong analytical and problem-solving abilities
Excellent communication and presentation skills
Superior organizational and time management capabilities
Proficiency with pharmacovigilance systems and databases
Proven experience in safety case management and regulatory reporting
Proficiency with safety databases and data analysis
Strong knowledge of ICH guidelines and regional requirements
Demonstrated mentoring abilities and process improvement skills
Experience in pharmaceutical or healthcare environments

Job Responsibility

Maintain expert-level knowledge of safety profiles, labeling, and global regulations
Lead development of project-specific procedures and workflows
Provide technical guidance to junior team members
Prepare for and participate in audits and inspections
Analyze metrics and drive continuous improvement
Collaborate with cross-functional teams on safety deliverables
Identify risks and recommend mitigation strategies
Ensure compliant documentation and archiving
Lead project management including safety procedure development and database setup
Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)

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

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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