Associate Director_Medical Safety Advisor_MBBS

- Provide PV and risk management expertise to internal and external customers

- Safety expert for product

- Maintain knowledge of product, product environment, and recent literature

- Maintain PV expertise, and understanding of international safety regulations and guidelines

- Lead cross functional Safety Management Teams (SMTs) and some Global Pharmacovigilance internal team(s)

- Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations

- Provide strategic and proactive safety input into development plans

- Support due diligence activities and pharmacovigilance agreements Impact

- Ongoing assessment of the safety status of the product

- Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, Statistical Analysis Plans, Program Safety Analysis Plans, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling

- Review, preparation, and/or contribution to questions from health authorities, ethics committees, Internal Review Boards (IRBs), external partners

- Management of product safety alerts, as needed

- Ensuring the Global Pharmacovigilance (GPV) position is well articulated to and understood by its internal and external customers

- Establishment of credibility of GSO function and of GPV Signal Detection and Assessment

- Responsible for signal detection and analysis

- Collaborate with Center of Excellence for Signal Detection and Data Mining and Safety Epidemiology group

- Identify and implement proactive safety analysis strategies to further define the safety profile for both marketed products and products in development

- Lead aggregate safety data review activities and coordinate safety surveillance activities

- Participate in safety governance process, including presentation of safety analyses

- Regulatory compliance

- Monitoring of risk mitigation tool effectiveness and adjustment of strategy, as needed

- Submission Activities:

- Represent safety position in cross functional submission teams

- Ensure generation, consistency, and quality of safety sections in submission documents

- For MD, Minimum of 3 years and for other degrees, minimum 5 years total experience in international PV or equivalent relevant industry experience with relevant clinical experience considered.

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