Senior Global Risk Management Plan Director
hace 4 días
About the Role
As a Senior Global Risk Management Plan Manager at Novartis Farmacéutica, you will play a key role in guiding 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. Your expertise will be instrumental in developing a robust and feasible Risk Management Plan (RMP) strategy aligned with the benefit-risk profile of the product, including for new submissions and innovative medicines.
Your Key Responsibilities
- Drive the development of a robust and feasible RMP strategy, 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 matrixes.
- 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.
- 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 Requirement
- At least 7 years in a pharmaceutical company, preferably in drug safety, clinical research, or regulatory affairs, with 3 or more years 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. Partners with other line functions and establishes effective relationships with stakeholders at all levels.
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