Designation/Role: Associate Medical Safety Director.

Location : Anywhere in India..

Qualification – MBBS with MD.

Experience : 9+ years.

Skills : Pharmacovigilance/Drug Safety Physician/Medical Safety/Medical Review/Signal identification/Signal Management/RMP(risk management plan)/Risk minimization measures/Benefit and risk assessment/ Health Authority requests/Aggregated safety Reports review/PBRER/DUSR/ACO/Drug Development/Global Safety Officer.

Key responsibilities:

• 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.

Only short-listed candidates will be notified immediately, in case your profile is not short listed then it will be in consideration for immediate future requirements.

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