Drug Safety Associate - Clinical Safety and Pharmacovigilance

Key Responsibilities

Record and review adverse reactions in the safety database for post marketing and clinical trial reports in accordance with applicable regulatory standards, with high accuracy and quality. Assessment and review of literature abstracts and full-text articles. Communicate with required stakeholders, as necessary, to carry out the operational responsibilities.

Carry out necessary administrative duties required for the job. Support effective functioning of PV projects (including but not limited to case processing, Literature Monitoring, Aggregate Reporting, Medical Writing, Signal Detection and Management, Medical Information and Risk Management etc.) in compliance with agreements and applicable regulations and guidelines.

Have ownership of assigned projects and tasks and ensure adherence to timelines and quality. Management of quality, compliance and documentation across PV projects. Other responsibilities as assigned by the Management.

Education

& Experience: B.Pharm / M.Pharm / BDS or equivalent qualification from a reputed institute recognized by Pharmacy Council of India 0-1 years of experience in drug safety/pharmacovigilance