Senior Risk Management Strategist

hace 4 semanas


Madrid, Madrid, España Federal Management System, Inc. A tiempo completo

About the Role

The Senior Global Risk Management Plan Manager will guide 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.

Key Responsibilities:

  • Drive the development of a robust and feasible Risk Management Plan (RMP) strategy aligned with the benefit-risk profile of the product, together with the Safety Lead and the SMT/GPT.
  • 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 with Good Pharmacovigilance Practices and other regulatory and internal requirements for Safety Risk management, as well as company and industry practices.
  • Represent the Risk Management function in the Safety management team, works 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.

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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