Medical Reviewer

- Accountable for the medical review of relevant clinical and spontaneous cases (including literature articles), medical assessment (including listedness and causality) and overall cohesiveness of individual case safety reports for a particular product or group of products on a national, regional, or global basis in line with regulatory and SOP requirements.

- Accountable for the final medical review of ICSRs including decisions on potential SUSARs in a timely fashion and ensuring that all necessary queries have been addressed.

- Perform tasks such as writing Analysis of Similar Events, safety letters, communication with the appropriate Safety Science Leader and where appropriate with the Clinical Science Group

- Responsible for generating, sending and tracking data queries, together with other PDSO staff, to Affiliates, SAE responsible and regional centers.

- Developing and maintaining knowledge of the appropriate disease biology areas for marketed drugs and drugs in development for which the Safety Operations Physician is responsible

- Working in collaboration with Roche as needed to ensure a timely response to relevant safety queries from Regional Centers, SAE responsible and corresponding affiliates, in particular those associated with SUSARS and SARs.

- Responsible for developing close links and communication with relevant Safety Operations Medical Lead, relevant Safety Operations Physicians groups maintaining awareness of critical AEs/and other issues for assigned product(s).

- Conducting/ supporting individual case safety data entry assessment and medical review according to client's SOPs and guidelines.

- Supporting the Drug Safety teams with medical concepts and awareness of product related topics to ensure quality of adverse event data processing.

- Membership of Drug Safety Team, representing the Safety Operations Physicians, working closely with global PDS personnel to deliver training on the interpretation of single case reports, interpretation of laboratory and other relevant data and on all other medical aspects of Pharmacovigilance.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.