Job title: Manager – Pharmacovigilance
Company: Piramal Capital & Housing Finance
Job description: Job Description Medical Reviewer Pharmacovigilance :Band 2A : Kurla, India :Reports to Head Pharmacovigilance Key responsibilities of this position include: * Conduct medical assessment/ review of ICSRs, aggregate safety reports and other Pharma
Job Description Medical Reviewer Pharmacovigilance : Band 2A : Kurla, India : Reports to Head Pharmacovigilance Key responsibilities of this position include: Conduct medical assessment/ review of ICSRs, aggregate safety reports and other Pharmacovigilance/ Safety documents. Monitor adverse event reporting submission based on regulatory requirements and timelines. Provide medical/ clinical guidance to case processing team. Support in signal management for company products. Respond to queries and requests related to safety of products and the pharmacovigilance system. Provide support during internal and external regulatory audits and inspections. Prepare and impart Pharmacovigilance Training to company personnel. Management of compliance with company Standard Operating Procedures and regulatory requirements. Maintain awareness of changes to/new regulations affecting pharmacovigilance activities. Communicate new or changed regulations to management and to relevant members of the department in order to initiate any change in processes. Builds and maintains good relationships across company units and different stakeholders in the organisation to meet regulatory commitments. Generation and Execution of company standard operating procedures (SOPs) Awareness and compliance to veterinary pharmacovigilance guidelines for EU, UK and USFDA. MD Pharmacology 0 – 1 years of experience Qualifications Qualifications – External MD Pharmacology 0 – 1 years of experience
Expected salary:
Location: Mumbai, Maharashtra
Job date: Sat, 13 Nov 2021 23:05:13 GMT
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