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
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