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Summary Guides the Safety Lead and the Safety Management Team (SMT)/Global Program Team (GPT) on Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk Management, including strategic support to new submissions and innovative products.
Provides support to the Safety Lead in the management, coordination, development, reviewing, and tracking of Safety Risk Management Plans (RMP) to ensure that documents are of high quality, regulatory compliant, and that logistics and distribution are handled in an appropriate and timely manner.
About the Role The Senior Manager Aggregate Reporting and Risk Management - RMP, liaises within the team and with the Global Product Safety Lead (GPSL) to ensure alignment & synergies between Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR) and Risk Management Plans (RMP).
Initiates the tracking of commitments and liaises with relevant functions that maintain and monitor the commitments.
Your Key Responsibilities Drive the development of a robust and feasible RMP strategy aligned with the benefit-risk profile of the product, together with the Safety Lead and the SMT/GPT, including for new submissions and innovative medicines, aligned with business priorities.
Guide strategic decisions and designing a robust worldwide implementation plan of the RMP strategy, including for new submissions and innovative medicines, by navigating complex stakeholder matrices.
Lead initiatives related to Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk Management, as well as company and industry practices.
Represent the RM function in the Safety Management Team, working in close collaboration with the Safety Lead, Regulatory, and other team members of the SMT/GPT (Clinical, Medical Affairs, Epidemiology, Biostatistics, Clinical Pharmacology, and Marketing, etc.)
for the risk minimization activities planning and defining of effectiveness, including for new submissions and innovative medicines.
Partner with the commercial team to integrate RMP requirements in marketing launch activities, as well as in communications to COs. Mentor new hires in the AR & RM team as RMP expert.
Deputize for the Team Lead or Group Head AR & RM in defined meetings and initiatives.
Experience/Professional Requirements At least 7 years in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs, with 3 or more years of expert knowledge in safety risk management.
Proven ability to work with large cross-functional teams in complex projects, including new submissions and innovative medicines.
Has demonstrated teamwork and effective communication skills.
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