Fidelity Health Services we are HIRING!
Designation: Assistant Manager
Profile: PSMF and SDEA
Qualification: B Pharma / M Pharma
Preference: Immediate Joiner
Drafting (authoring) of Pharmacovigilance System Master File (PSMF) and Safety
Data Exchange Agreements (SDEA).
‣ Update PSMF and SDEA (biparty / triparty / quadripartite) and its maintenance for global MAHS.
04-05 years’ experience in PV function and at least 01-02 years of experience in PSMF and SDEA authoring.
▸ Should have a good knowledge about Global PV regulations and requirements. ▸ Should have clear understanding of regulations of EU PSMF and SDEA requirements.
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