Piramal Group job vacancy for Manager Pharmacovigilance, Medical reviewer @ Mumbai
Manager Pharmacovigilance, Medical reviewer
Mumbai, Maharashtra, India
JOB DESCRIPTION
1)Review and conduct medical assessment of Human and Veterinary Pharmacovigilance/ safety documents (including ICSRs and aggregate safety reports such as PADER/PSUR).
2)Perform medical review of serious and non-serious ICSRs with importance on the causality, seriousness, expectedness, MedDRA coding etc.
3)Review of literature articles for identification of ICSRs, safety and efficacy information for inclusion in aggregate reports, RMPs and signal reports.
4)Response to queries and requests related to safety of products and the pharmacovigilance system from internal and external stakeholders including health authorities.
5)Review of ICSRs received from sources such as Health authority, Partners, Spontaneous and Literature.
6)Facilitation of follow up for cases and product complaints.
7)Provide regular feedbacks to the case processors and ensure case quality.
8)Involvement in case quality improvement process and its implementation.
9)Provide trainings to the team for updates in the global pharmacovigilance guidelines and product trainings.
10)Preparation for Internal or External audits and inspections.
QUALIFICATIONS
ESSENTIAL QUALIFICATION: MBBS/MD Pharma
