Akum Drugs & Pharmaceuticals Hiring Pharmacovigilance Executive/ Sr. Executive

Job description

Job Location:- Haridwar (Uttarakhand)

Experience:- 3-5 Years

• Responsible for RMP (Risk Management Plan) development and submission to applicable regulatory authority.
• Responsible for Signal detection and continuous monitoring of safety profile of all medical products.
• Responsible for PSUR (Periodic Safety Update Report) development and submission to applicable regulatory authority.
• Responsible for handling Regulatory queries related to the PV documents.
• To assist in pharmacovigilance training to team members and other departments related to PV procedures and regulatory obligations.
• To assist head of the department in preparation /revision of Standard Operating Procedures/Work Instructions.
• Responsible for global and local literature surveillance.
• To review and approve final ADR/AE assessment report and related activities.
• Responsible for coordinating with different Marketing Authorization Holders (MAHs)/ clients/ Regulatory Authorities on a 24 hour basis related to Pharmacovigilance activities & queries.
• Will be involved in audit/inspection plans and Corrective Actions Preventative Actions (CAPAs).
• To evaluate potential medically relevant pharmaceutical product complaints.

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