Job Details

Aggregate Report management, including strategy, medical review and finalization of aggregate safety reports for assigned products, such as PSURs, PBRERs, ARs and DSURs,
Working on pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and innovative Risk Management Plans (RMPs).
Contribute to and lead initiatives for process improvement and consistency regarding aggregate reporting and signal detection management for clients medicinal products.
Provide technical support in the writing of medical/PV sections of PSR.
Medical review and evaluation of the safety data as part of - ICSR management including MedDRA coding, labelling assessment and causality assessment.
Contributing as part of the Medical review team to develop processes, training plans/modules and SOPs.

• Educational qualifications: A minimum of MBBS/ MBBS, MD from a recognized university.
• Pharmacovigilance experience (aggregate report management, REMS, RMPs, signal detection) either in a pharmaceutical company or with a CRO.
• Good understanding of clinical development processes including principles of clinical study operations, and ICH-GCP guidelines.

Reference ID - GH/Pharma/Senior Manager - Drug Safety