Pharmacovigilance Manager

Preparation of aggregate reports including: PSUR, PBRER, PADER, DSURs, ACOs.Conduct quality review of aggregate reports, and quality review of reports generated by the vendorEnsure all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements.Prepare data listings from the global safety database, where system access has been...

Preparation of aggregate reports including: PSUR, PBRER, PADER, DSURs, ACOs.Conduct quality review of aggregate reports, and quality review of reports generated by the vendorEnsure all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements.Prepare data listings from the global safety database, where system access has been...

Preparation of aggregate reports including: PSUR, PBRER, PADER, DSURs, ACOs.Conduct quality review of aggregate reports, and quality review of reports generated by the vendorEnsure all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements.Prepare data listings from the global safety database, where system access has been...

**Job description** - Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable) - Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners - Supports PV Clinical Specialists in tasks and projects as needed - Responsible for identifying and developing...

**Job description** - Responsible for review of investigational new drug safety reports (INDSR) and submission to FDA (as applicable) - Responsible for negotiation and implementation of pharmacovigilance agreements (PVA) with business partners - Supports PV Clinical Specialists in tasks and projects as needed - Responsible for identifying and developing...

Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...

Designation: Asst Manager/Manager – Medicoregulatory AffairsDepartment: Medicoregulatory AffairsJob location :Kandivali-West, MumbaiResponsibilitiesI To independently review following applications online through Sugam Portal to CDSCO:Import license of reference product for BE studiesBE study NOC for export purposeManufacture of new drugs to be introduced...

**About Apotex Inc.** Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

Job Title: Manager, Consulting – Pharmaceuticals / R&D ProcurementLocation: MumbaiExperience Level: 4+ years in procurement consulting, with at least 2-3 years focused on pharmaceutical R&D categoriesRequired Qualifications:- MBA / PGDM preferred, ideally with a background in Life Sciences, Supply Chain from Tier -1 Colleges- Strong understanding of R&D...

Job Title: Manager, Consulting – Pharmaceuticals / R&D ProcurementLocation: MumbaiExperience Level: 4+ years in procurement consulting, with at least 2-3 years focused on pharmaceutical R&D categoriesRequired Qualifications:- MBA / PGDM preferred, ideally with a background in Life Sciences, Supply Chain from Tier -1 Colleges- Strong understanding of R&D...