Manager, Drug Safety Physician

Job Details

• Conduct Medical Review and assessment of ICSR s into the safety database.
• Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment.
• Review and respond to any queries / comments from the case owner in the patient safety database. Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers.
• Maintain strong GPVP and GCP knowledge. Following ICH and EMA guidelines strongly and implementing them appropriately.
• Train and mentor PV associates on event capturing and general PV conventions as required.
• Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas.
• Escalate complex case issues on client products to Team Lead / Line Manager.
• Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature. Provision of scientific input in the course of literature surveillance service.
• Maintain good knowledge of databases, regulations, guidelines and SOP s.
• To actively communicate and participate in internal project meetings.
• Participation in internal and external audits / inspections.
• Review and preparation of periodic safety reports (e.g., PSURs, PBRER) and RMPs.
• Collaborate with Global Pharmacovigilance team with respect to Signal Detection and its processes.
• Perform any other drug safety related activities as assigned.
• .Degree in Medicine. PG degree in any discipline is an advantage but not mandatory.
• Minimum 8 years of relevant experience in Pharmacovigilance & Drug Safety.
• Strong interpersonal and organizational skills to be a good team player.
• High sense of responsibility, dedication, and desire to work under pressure as required.
• Highly service oriented. Previous exposure to corporate environment, pharma and life sciences industry is an advantage.
• Good communication skills. Fluent in English- spoken and written.

Skills Required

PSUR