Pharmacovigilance Deliverable Check at Sanofi, M.Pharm, Pharm D candidates apply!
Pharmacovigilance Deliverable Check at Sanofi. Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
Main Responsibilities of a Pharmacovigilance Deliverable Check at Sanofi:
- Perform the QA review of the ICSRs, PBRERs, Signal/Safety governance activities and literature screening output against the applicable source documents/versions.
- For ICSRs: Quality Review of ICSRs in PV Safety Database against all the relevant source documents of an assigned case version or previous case versions when required. Categorizing and updating the ICSR QA observations.
- For Signal:Review of Signal/Safety governance activities in related tools/platforms. Finding out the discrepancies and categorizing these observations into critical, major or minor findings.
- Ad hoc: Literature, PSR/RMP should be reviewed as needed. Check consistency between other PV docs such as, PVA and related reporting rules. Send out the observations to the respective stakeholders for obtaining root cause analysis (RCA) for the observations. Follow up for obtaining corrective/preventive action (CAPA) for the observations.
- Peer review of ICSRs, Signal/Safety Governance Activities and Aggregate Reports (PBRERs) against the applicable source documents and updated checklist and applicable tools. Preparation and Presentation of the data to the responsible stakeholders in an appropriate forum as required.
About You: Experience:
- Pharmacovigilance Deliverable Check at Sanofi should have experience in the Pharmaceutical or Biopharmaceutical industry, ideally 5+ years in consumer healthcare pharmaceutical industry.
- Minimum of 5 years of experience in ICH-GxP-related Quality operations and Compliance, of which 3-4 years’ experience in PV, is mandatory.
- Knowledge of international regulations/Guidelines/Good Practices pertaining to the ICH-GxP.
Soft skills: Stakeholder management, Strong negotiation and communication skills, and ability to operate effectively in a global environment and across-line functions. Attention to details, Analytic, pro-active and effective problem-solving skills.
Technical skills: Pharmacovigilance Deliverable Check at Sanofi should have Validation tools (database, signal management tools). Experience in PV Audits and Inspection Management. Good depth understanding of Quality Risk Management and Quality systems.
Education: Scientific background: M.Pharm, Pharm D or Master’s Degree in Human Health or License Degree in Human Health Sciences.
Equal Opportunities Statement: At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Keywords: Pharmacovigilance, Sanofi, Quality Review, Signal Management, Stakeholder Management, Pharmaceutical Industry.Pharmacovigilance Deliverable Check at Sanofi
