As a global safety officer, provides PV expertise for assigned products, maintains PV expertise, and understanding of international safety regulations and guidelines. Provides and maintains PV and risk management expertise to internal and external customers.
Maintains knowledge of product, their environment and recent literature.
Communicates and represents PV data evaluation, interpretation and summary or conclusions as relevant.
Responsible for signal detection and analysis. as well as review, preparation, and/or contribution to responses to questions from health authorities, ethics committees, Internal Review Boards (IRBs), external partners.
Manages product safety alerts, as needed.
Responsible for Identifying and implementing proactive safety analysis strategies to further define the safety profile of the product.
Provides proactive risk assessment. Responsible for documenting, coordinating, reviewing and validating periodic reports, e.g.: RMP update, IND Annual Report, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report, Health Hazard Evaluation etc., leads the preparation of clinical overview to support labelling changes and oversees the safety part of the Company Core Safety Information (CCSI/CCDS) creation/ update.
Prepares for and particpates in the SMC and SMT meetings and also provides inputs during labellling working group meetings. Participates and provides inputs for audit related activities (internal and external partners).
Prepare the List of safety concerns/ list of safety topics for a product based on the existing RSI and properties of the product.
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