Provide support to the Brand Safety Leader/Pharmacovigilance Leader (PVL/BSL) in monitoring the safety profile of assigned products by providing quality deliverables within agreed timeframes and adhering to a high standard of accuracy in compliance with business rules, standard operating procedures and global and local regulatory requirements.
1. Prepares medical input to aggregate, clinical and safety regulatory reports
2. Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Company drugs.
3. Provides Pharmacovigilance input into updates of the Company Core Data Sheet.
4. Leads cross-functional teams, such as safety management teams and operational work groups [Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments]
1. Assist the BSL/PVL in monitoring the safety profile of products potentially including activities such as literature review, evaluation of individual cases or signal detection.
2. Performs medical assessment and related activities for single cases, including collecting addi-tional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, literature review and preparation of investigator notifications and periodic medical assessments for ethics committees.
3. Together with the BSL/PVL, co-author the PSUR including analytical input to PSUR for known and potential risks defined in the RMP.
4. With BSL/PVL, assist in the development, maintenance and implementation of the RMP including the coordination with other line functions for associated activities such as updates, management of large datasets for analysis purposes and the ongoing tracking of commitments and effectiveness measures
5. Assist in evaluating and writing other safety deliverables including but not limited to clinical overviews, ad hoc health authority queries, drug safety product profile (DSPP), drug safety update report (DSUR)
6. Assist in providing safety input to DRA and clinical documents (e.g. core data sheet and investigator brochure)
7. Play an active role in standing and ad hoc Safety Management Team (SMT) and Safety Project Team (SPT) meetings
8. Play an active role in SIGDET and MSRB meetings including preparatory activities
9. Interface with the clinical team for safety matters including follow-up on events of interest and input into site queries regarding adverse events, updating on PVO requirements
10. Lead the training and mentoring of internal and cross-functional team members