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RA Pharmacovigilance

  • | 3 - 5 Years
  • | 200000 - 300000
  • | Navi Mumbai

Job ID

SS_JOB676

Job Location

Navi Mumbai

Industry

Pharma / Biotech / Clinical Research

Description

The position will be an Executive level. Main focus of the candidate will be handling Pharmacovigilance activity along with regulatory. Profile and job description Scope & Missions Complaints management quality & safety Product complaint management ( to be confirmed with QA) Centralization of PC Supervise investigation and conclusion Communication of the result to customer and others stakeholders involved in the process Reporting & metrics Maintenance Quality System management for product complaint management Vigilance Local QPPV in India Implementation of the process according to Corporate SOP Unique contact point for safety notification in Indian territories Initiate case processing ( send to corporate) Documentation of case Local literature in key local publication in order to identify some case report published in the literature Local regulatory watch Local PSUR schedule management and PSUR management for local products ( if any) Local signal detection for local products if any Management of dealers and distributors: SDEA, audit, … reconciliation…. Maintenance of Quality system management Maintenance of PVMF according to template provided by Corporate Medical information management Administrative tasks for regulatory submission KEY Expertise : Strong knowledge in pharmacovigilance & Product Complaint management ( EU regulation, GVP,) Case processing PSUR Quality system management Medical device vigilance knowledge would be interesting

Skills

Pharmacovigilance

Industry:

Pharma / Biotech / Clinical Research

Experience requirements

3 - 5 Years

Qualifications:

Any Graduate

Company Profile

Contact : Juhi Agrawal

Email :  juhi@white-force.com

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