Senior Global Risk Management Plan Director

hace 4 semanas


Barcelona, Barcelona, España Novartis A tiempo completo

Job Summary
Novartis is seeking a highly skilled Senior Global Risk Management Plan Manager to join our team. As a key member of our Safety management team, you will be responsible for guiding strategic decisions and designing a robust worldwide implementation plan of the Risk Management strategy.

About the Role
The Senior Manager Aggregate Reporting and Risk Management - RMP will lead initiatives related to Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management. You will work closely with the Safety Lead, Regulatory and other team members of the SMT/GPT to ensure alignment synergies between Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR) and Risk Management Plans (RMP).

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.
• Guide strategic decisions and design 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 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 ARRM in defined meetings and initiatives.

Requirements
• 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.
• Knowledge of worldwide regulatory requirements for drug registration (scientific and technical aspects) and clinical drug development.
• Proven ability to interpret and discuss efficacy and safety data relating to multiple therapeutic areas to the level required for delivering successful RMPs and aggregate safety reports.
• Solid Medical/Scientific writing and verbal skills.
• Languages: Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) desirable.
• Education: (minimum/desirable): Scientific Degree required. Advanced degree (Masters, PharmD or PhD) desirable.

Why Novartis?
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. We are an equal opportunities employer and welcome applications from all qualified candidates.



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