Executive-pharmacovigilance / Ra
2 weeks ago
**Job Detail**:
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- Job ID
- 11008
- Salary In Lacs
- 5Lacs - 10Lacs
- Experience
- 3years - 5Years
- Location
- Mumbai
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Position: - Executive-Pharmacovigilance / RA
Location: Taloja, Navi Mumbai
Experience: 2+ years
**Required skills**:
- Pharmacovigilance knowledge
- Knowledge of CDSCO documentation
- Submitting documents on Sugam Portal
- Complaint handling along with PV
**Scope & Missions**
- Complaints management quality & safety
- Product complaint management ( to be confirmed with QA)
o Centralization of PC
o Supervise investigation and conclusion
o Communication of the result to customer and others stakeholders involved in the process
o Reporting & metrics
o Maintenance Quality System management for product complaint management
**Vigilance**
o Local QPPV in India
o Implementation of the process according to Corporate SOP
o Unique contact point for safety notification in Indian territories
o Initiate case processing ( send to corporate)
o Documentation of case
o Local literature in key local publication in order to identify some case report published in the literature
o Local regulatory watch
o Local PSUR schedule management and PSUR management for local products ( if any)
o Local signal detection for local products if any
o Management of dealers and distributors: SDEA, audit,reconciliation.
o Maintenance of Quality system management
o 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
**Required skills**:
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Pharmacovigilance
ra
