Job Details

• The Physician will play a key role in executing and managing Pharmacovigilance projects for global clients and will report to Director, PV for their day-to-day project work. 
• The Physicians perform medical evaluation of reports in PV projects with strict adherence to the Standard Operating Procedures and Work Instructions valid at that time and should be available for internal or external audit.

• Candidate with 3-5 years of Aggregate report writing and medical review experience (Pharmacovigilance) either in a pharmaceutical company or with a CRO
• Team management/ Project management experience
• Candidates with additional experience of Medical Review of safety data for purpose of expedited/ periodic reporting for clients products including MedDRA coding, labelling assessment and causality assessment would be prioritized for interview
• Signal Detection and Management for clients medicinal products, per applicable regulations globally
• Preparation of responses for queries to be submitted to regulatory authorities
• Contributing as part of the Medical review team to develop processes, training plans/modules and SOPs
• Good understanding of clinical development processes including principles of clinical study operations, and ICH-GCP guidelines.

Reference ID - GH/IT/JC//05102018//78823/Drug safety Physician