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Pharmacovigilance Executive | Akums Drugs & Pharmaceuticals | Haridwar

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Akums Drugs & Pharmaceuticals Ltd. is the largest contract manufacturing company engaged in the manufacturing of pharmaceutical formulation, ayurvedic/herbal preparations, hormones, nutraceuticals, and more. Quality, innovations & customer satisfaction are virtues at Akums. The approach is technologically driven to serve the emerging needs in the ever-expanding market. The 9 states of art facilities are dedicated to separate dosage forms across therapeutic segments. The infrastructure is equipped with sophisticated and ultra-modern equipment & machines, with huge manufacturing capacities in all sections. In our continuous pursuit of Healthier today and tomorrow, we are working towards redesigning global healthcare

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Designation: Pharmacovigilance Executive

Location: Haridwar, Uttrakhand, India

Job Description:

  • Responsible for PSUR (Periodic Safety Update Report) development and submission to applicable regulatory authority.
  • To assist in pharmacovigilance training to team members and other departments related to PV procedures and regulatory obligations.
  • To assist the head of the department in preparation /revision of Standard Operating Procedures/Work Instructions.

  • Responsible for conducting overall Pharmacovigilance activities and maintenance of Pharmacovigilance (PV) safety database.
  • Responsible for the preparation and maintenance of the Pharmacovigilance System Master File (PSMF).
  • Responsible for global and local literature surveillance.
  • Responsible for ICSR management and submission to applicable regulatory authority.
  • Responsible for the development and maintenance of the PV Safety Data Exchange Agreement (SDEA) of different clients.
  • To review and approve the final ADR/AE assessment report and related activities.
  • Responsible for handling and reporting of all SAEs to DCGI and other applicable regulatory authority.
  • Responsible for RMP (Risk Management Plan) development and submission to an applicable regulatory authority.
  • Responsible for Signal detection and continuous monitoring of the safety profile of all medical products.
  • Responsible for coordinating with different Marketing Authorization Holders (MAHs)/ clients/ Regulatory Authorities on a 24-hour basis related to Pharmacovigilance activities & queries.
  • Responsible for PMS (Post Marketing Surveillance) studies/noninterventional observational cohort studies etc.
  • Will be involved in audit/inspection plans and Corrective Actions Preventative Actions (CAPAs).
  • To evaluate potential medically relevant pharmaceutical product complaints.

Qualification: B.Pharma/M.Pharma

Experience: 3-5 Years

Salary: Negotiable

Contact Details:

Mr. Gobind Singh

gobindsingh.hr@akums.in

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