Urgent opening for Executive-Pharmacovigilance / RA at Navi Mumbai Location
Full time in Pharma, Biotech, Clinical Research Shortlist Email JobJob Detail
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Job ID 11008
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Salary In Lacs 5Lacs - 10Lacs
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Experience 3years - 5Years
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Location Mumbai
Job Description
Position: – Executive-Pharmacovigilance / RA
Location: Taloja, Navi Mumbai
Experience: 2+ years
Required skills:Â
· Pharmacovigilance knowledge
· Knowledge of CDSCO documentation
· Submitting documents on Sugam Portal
· Complaint handling along with PV
Job Description:Â
The position will be an Executive level. Main focus of the candidate will be handling Pharmacovigilance activity along with regulatory.
Scope & MissionsÂ
•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
VigilanceÂ
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 :Â
· Strong knowledge in pharmacovigilance & Product Complaint management ( EU regulation, GVP,)
· Case processing
· PSUR
· Quality system management
· Medical device vigilance knowledge would be interesting