Sr Risk Management Scientist, Global Pharmacovigilance

Job reputed company reputed company 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 reputed company (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 reputed company 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 reputed company

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 reputed company reporting of safety issues to Product Safety Review reputed company (PSRB), reputed company Management Review (QMR) and PV Leadership in compliance with internal procedures and to ensure reputed company communication of risk is achieved and reputed company course of reputed company 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, reputed company 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 reputed company 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 reputed company 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 reputed company 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 / reputed company.
• Ability to document, plan, market, and execute programs.
• Established project management skills.
• Strong reputed company record of scientific and analytical thinking.

Inclusion and Diversity reputed company is an Equal Opportunity Employer where inclusion reputed company. Employment reputed company are made without reputed company to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or reputed company, age, disability, protected veteran status or other characteristics protected by law. Behaviors We expect reputed company to live and breathe our behaviors: to reputed company with humility and build trust; reputed company with transparency; deliver with reputed company, and drive ownership – always with unyielding reputed company. Total Rewards Our total rewards are designed to unlock your ambition by giving you the reputed company 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 reputed company, and you’ll be surrounded by reputed company in a culture that fosters care, collaboration and support. Additional Information Relocation Assistance Provided: No Apply tot his job Apply To this Job