Safety Evaluation

2 tygodni temu

Warszawa, Polska GSK Pełny etat

Safety Evaluation & Risk Management (SERM) Scientific Director Join to apply for the Safety Evaluation & Risk Management (SERM) Scientific Director role at GSK Location: GSK HQ, India – West Bengal – Alipurduar, Warsaw Posted on Nov Position Summary: The SERM Scientific Director will provide in-depth medical/scientific expertise in the safety evaluation and risk management of key GSK assets or in clinical development and/or post-marketing settings. They will ensure scientifically sound review and interpretation of data, manage safety issues, and provide recommendations for risk characterization and communication. Key Responsibilities Lead pharmacovigilance and risk management planning, developing strategies for evaluating issues in clinical trials. Lead the safety component of global regulatory submissions and safety governance. Perform expert evaluation of literature, clinical data synthesis, analysis, and interpretation. Make high-quality decisions, resolve problems creatively, and prioritize tasks to meet deadlines. Collaborate cross-functionally to implement risk-reduction strategies and maintain product safety. Represent GSK in cross-functional teams, lead ad hoc safety issue resolution and process improvement initiatives. Communicate safety recommendations to senior staff and governance committees; engage with regulatory authorities and external partners. Prepare for inspections and audits, ensuring safety processes are audit-ready. Basic Qualifications Bachelor's Degree required. Experience in vaccine pharmacovigilance and safety signal detection. Robust benefit-risk and signal assessment expertise for vaccines. Significant pharmacovigilance experience in safety evaluation and risk management across clinical development and post-marketing. Knowledge of international pharmacovigilance requirements (ICH, GVP, CIOMS). Why GSK? GSK is a global biopharma company dedicated to uniting science, technology, and talent to advance disease prevention and treatment. We are committed to creating an inclusive environment where people can thrive. Equal Opportunity Employer – all qualified applicants receive equal consideration without regard to protected characteristics. Contact us for potential support accommodations at or . #J-18808-Ljbffr

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    Warszawa, Mazovia, Polska GSK Pełny etat 900 000 zł - 1 200 000 zł rocznie

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    1 tydzień temu

    Warszawa, Mazovia, Polska GSK Pełny etat 120 000 zł - 180 000 zł rocznie

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    Warszawa, Polska GSK Pełny etat

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