- Record and review adverse reactions in the safety database for post-marketing and clinical trial reports in accordance with regulatory standards.
- Assess and review literature abstracts and full-text articles.
- Communicate with required stakeholders as necessary.
- Perform necessary administrative duties.
- Support effective functioning of pharmacovigilance (PV) projects, including but not limited to case processing, literature monitoring, aggregate reporting, medical writing, signal detection and management, medical information, and risk management.
- Ensure adherence to timelines and quality for assigned projects and tasks.
- Manage quality, compliance, and documentation across PV projects.
- Work with internal and external stakeholders to ensure compliance with agreements and applicable regulations.
- Train and mentor personnel as needed.
- Represent the department during audits and inspections.
- Author and review SOPs and other relevant documents.
- Perform other responsibilities as assigned by management.
Qualifications:
- Education: B.Pharm/M.Pharm/BDS or equivalent qualification from a reputed institute recognized by the Pharmacy Council of India.
- Experience: 2-4 years of experience in drug safety/pharmacovigilance.
- Skills: Pharmacovigilance, regulatory affairs, and other relevant skills.
