Manager, Patient Safety and Pharmacovigilance Operations 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

Senior Medical Director / Medical Director, Pharmacovigilance

The Medical Director of Pharmacovigilance (PV) will provide clinical/scientific/...

Location

United States , Cambridge, MA

Salary:

210000.00 - 375000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

MD required, Board certification preferred with 15+ years of experience
5+ years of pharmacovigilance experience
Experience in cell or gene therapy preferred
Experience as safety lead for asset/approved drug product e.g. Global Safety Lead
Oversight experience of global medical safety activities
Demonstrated knowledge of global PV regulatory environment
Working knowledge of industry standard safety databases (ARGUS and ARISg)
Knowledge of MedDRA dictionary
Excellent knowledge of drug development process
Experience reviewing cumulative safety data

Job Responsibility

Provide dynamic leadership, strategic direction and governance of patient safety and PV risk management activities
Lead signal detection and risk management activities for assigned products
Lead proactive and ongoing analysis and interpretation of non-clinical data, clinical, post-marketing, scientific literature
Lead PV during interactions with Regulatory Authorities (RA)
Perform individual case safety report (ICSR) medical review
Lead multidisciplinary Safety Management Committee (SMC) and Executive Safety Committee (ESC)
Serve as PV SME in support of regulatory filing activities
Collaborate with cross functional team
Address internal/external safety-related requests
Provide guidance regarding Statistical Analysis Plans

Fulltime

Medical Reviewer

The Medical Reviewer (MR) is responsible for providing medical review for indivi...

Location

India , Gurgaon

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, Baxter causality assessment
Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment
Potential review of periodic documents, and product labels
Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities
Support the Safety Operations team, providing expertise for the case processing team for medical questions e.g., coding of events, understanding coding conventions, splitting of cases etc.
Maintain knowledge of global regulatory authority regulations (especially FDA and EMA)
Contribute to the training, leadership and continuing education for all departmental staff
May perform benefit-risk safety analysis, including: safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans and REMS, Regulatory Authority assessment reports and queries, and periodic documents, such as PSURs, PBRERs, and PADERs

Job Responsibility

Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, Baxter causality assessment
Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment
Potential review of periodic documents, and product labels
Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities
Support the Safety Operations team, providing expertise for the case processing team for medical questions e.g., coding of events, understanding coding conventions, splitting of cases etc.
Maintain knowledge of global regulatory authority regulations (especially FDA and EMA)
Contribute to the training, leadership and continuing education for all departmental staff
May perform benefit-risk safety analysis, including: safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans and REMS, Regulatory Authority assessment reports and queries, and periodic documents, such as PSURs, PBRERs, and PADERs

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

Medical Reviewer

The Medical Reviewer (MR) is responsible for providing medical review for indivi...

Location

India , Gurgaon

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, Baxter causality assessment
Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment
Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities
Support the Safety Operations team, providing expertise for the case processing team for medical questions e.g., coding of events, understanding coding conventions, splitting of cases etc
Maintain knowledge of global regulatory authority regulations (especially FDA and EMA)
Contribute to the training, leadership and continuing education for all departmental staff
May perform benefit-risk safety analysis, including: safety surveillance activities for potential safety signals, aggregate safety data review, risk management plans and REMS, Regulatory Authority assessment reports and queries, and periodic documents, such as PSURs, PBRERs, and PADERs

Job Responsibility

Provide medical review for individual case safety reports, including: coding, seriousness, expectedness, Baxter causality assessment
Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment
Potential review of periodic documents, and product labels

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

Sales Representative

As a Sales Representative at Baxter, you will be responsible for managing assign...

Location

Croatia , Zagreb

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Master’s degree preferred (Science, Commercial, Medical, …)
Significant experience in Medical Devices or Pharmaceutical businesses – min 2 years Hospital business and clinical use product sales needed, both in Sales, National Accounts and Bids procedures and requirements
Experience in ICU, surgery, gastroenterology departments is advantage

Job Responsibility

Develop and implement a sales business plan and key customer satisfaction goals for the assigned accounts and/or sales area
Maintain, develop, and consolidate relationships with all essential functions within the National Healthcare System at the sales area level and at the Hospital level (where applicable)
Responsible for the business result of the assigned accounts and/or sales area
Bring in market intelligence and customer knowledge
Closely work with his supervisor while monitoring regional/local key policies that may affect Hospital business in the designated sales area
Maintain a watching brief on developments within the sales area and customer’s organization which may affect future business in co-operation with Marketing
Analyze account attractiveness and develop the account plan including sales, market share and required resources in cooperation with Marketing
Make field visits, product presentations, seminars, customer training and establish strong relationships with HCPs. key decision makers and committees within the sales area and buying organizations for Hospital
Develop the business activity of the company
Participates in the development of promotional materials, obtaining expert literature, organizes and leads professional conferences, education, courses and seminars and participates in Third-party organized events

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Manager, Patient Safety and Pharmacovigilance Operations

Kailera Therapeutics

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 06, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Manager, Patient Safety and Pharmacovigilance Operations

Senior Physician, Patient Safety

Senior Medical Director / Medical Director, Pharmacovigilance

Medical Reviewer

Patient Safety Associate II/Patient Safety Specialist - Japanese

Senior Manager, Patient Safety and Pharmacovigilance Quality

Medical Reviewer

Executive Director, Medicine Development Leader

Sales Representative

Manager, Patient Safety and Pharmacovigilance Operations

Kailera Therapeutics

Location:United States , Waltham

Category:Research and Development

Contract Type:Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:January 06, 2026

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Manager, Patient Safety and Pharmacovigilance Operations

Senior Physician, Patient Safety

Senior Medical Director / Medical Director, Pharmacovigilance

Medical Reviewer

Patient Safety Associate II/Patient Safety Specialist - Japanese

Senior Manager, Patient Safety and Pharmacovigilance Quality

Medical Reviewer

Executive Director, Medicine Development Leader

Sales Representative

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Job Posted:
January 06, 2026