PharmaLeaf Mumbai Hiring RA & PV Specialist

PharmaLeaf Mumbai Hiring RA & PV Specialist

21 March, 2022

About the job

3-5 years exp. in Regulatory – Pharmacovigilance

  • From pharma product based establishment/company (Not CRO)
  • Products: Generics & Nutraceutical – India markets

Qualification : M.Pharm (Pharmacology, Pharm D, BAMS/BDS) Clinical domain

  1. Regulatory Strategy: To support Regulatory strategy for the execution of PV activities
  2. Review of Documents/Dossiers and Gap Analysis: To assess & analyze timely processing of new and follow up reports of adverse effects & side-effects ( as well as SAE & Suspected and Unexpected Serious Adverse event Reaction (SUSARs))
  3. Communication & Coordination: with vendors, Regulatory agencies, health-care professionals; To collect ADR report and submit to CDSCO, India and also to check for the precedence of the similar ADR; coordinate with cross functional teams to ensure PV compliance as per PvPi guidelines for marketed products
  4. Technical Writing of Regulatory Documents: Well versed in literature search & extend PV support safety of the product; Knowledge of PvPi module to prepare internal SOPs
  5. Dossier Publishing and Archival: Publishing of the dossier in hardcopy and softcopy for the submission at the agency. To submit the PSUR, DSUR, bi-annual status reports to CDSCO
  6. Quality Control: QC of the documents/dossier before dispatch or final submission on the Portal
  7. Technical Liaison with the regulatory agency: Communication and Co-ordination with the Agency (Assistant Drug Controller/Drug Inspector CDSCO, SLA, IPC, FSSAI)

Apply through below link

(2) RA & PV Specialist | PharmaLeaf India Private Limited | LinkedIn

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