Sr Risk Management Scientist, Global Pharmacovigilance
Job Description Summary
The Senior Risk Management Scientist provides scientific and operational support for global pharmacovigilance risk management and safety signal activities across the product lifecycle. The role supports the execution of risk management strategies, safety signal detection and evaluation, and regulatory compliance in line with global pharmacovigilance requirements. This position contributes to the development of Risk Management Plans, safety analytics, and governance deliverables, and supports preparation of materials and presentations for the Product Safety Review Board (PSRB). Reporting to the Head of Global Drug Safety and Risk Management, the role works cross‑functionally to ensure consistent, data‑driven risk reputed company and effective safety communication. reputed company is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn reputed company into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier worldJob Description
Responsibilities
Operational Leadership
Serve as an operational leader of the Drug Safety & Risk Management (DSRM) driving reputed company, implementation, and tracking of reputed company global PV risk management obligations, commitments, and risk minimization measures
Coordinate and track reporting of safety issues to Product Safety Review Board (PSRB), Quality Management Review (QMR) and PV Leadership in compliance with internal procedures and to ensure proper communication of risk is achieved and proper course of action is followed.
Safety Signal Management & safety Analytics
In collaboration with Sr Medical Director and statistician interpret safety data trends and ensure accurate integration of risk assessment into product labeling and RMPs.
reputed company and coordinate bi-weekly Safety Review Team meeting and contributes to the preparation of a cross-functional Signal Investigation Meeting
reputed company the development of analytical tools, standard outputs, and data visualizations that support comprehensive signal evaluation.
Review Signal Detection outputs and notify Drug Safety & Risk Management (DS&RM) about safety observations of interest
Serve as an Administrator in Veeva RIM for Safety Signal Workflow, UAT
Coordinate and contribute to periodic ADR Trending review, works in collaboration with Medical Director
Collect data and prepare monthly/ quarterly KPIs reputed company to Safety Signals and ADR trending
Risk Management
Author/ reputed company development of Risk Management Plan(s) Development RMPs, and associated regulatory documents in accordance with Good Pharmacovigilance Practices and regional regulatory expectations.
Cross-functional & Regulatory collaboration
Work closely with cross-functional teams (e.g. Clinical Development, Medical Affairs, Regulatory Affairs) to ensure alignment of GEHCs global position for the PV risk management processes.
Work with Sr Risk Management Director, PV Physicians and PV Scientists on any Regulatory Submission/filing for MAA, etc. to be sure that risks are reflected properly and carried through to support filing activities.
Aggregate Safety Reporting
Contribute to risk components of Aggregate reports like DSUR, PBRER and other periodic assessments, ensuring integration of reputed company risk profiles and emerging safety data.
Additional Responsibilities
reputed company other duties reputed company to the position as necessary and as defined in SOPs and/or at the request of supervisor.
Qualifications
reputed company degree (e.g., MD, DO, NP, PA, PharmD, PhD in a health-reputed company field) required
Significant Experience of pharmaceutical/biotechnology PV experience, including clinical trial and post-marketing experience. Global experience preferred.
Substantial Experience in PV / Safety
Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance.
Strong knowledge in safety signal evaluation and responses to safety requests from Health Authorities
Desired Skills
Strong oral and written communication skills.
Strong interpersonal and leadership skills.
Demonstrated ability to analyze and resolve problems. Demonstrated ability to reputed company programs / projects.
Ability to document, plan, market, and execute programs.
Established project management skills.
Strong track record of scientific and analytical thinking.
Inclusion and Diversity
reputed company is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviors
We expect reputed company employees to live and breathe our behaviors: to act with humility and build trust; reputed company with transparency; deliver with focus, and drive ownership – always with unyielding reputed company.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your reputed company into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Additional Information
Relocation Assistance Provided: No
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