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Senior Medical Director, Global Patient Safety and Risk Management
hace 2 meses
Mymenopauserx, Llc is seeking a highly experienced Senior Medical Director to lead our Global Patient Safety and Risk Management efforts. As a key member of our team, you will be responsible for providing strategic and operational oversight of our Safety Surveillance and Risk Management activities.
Key Responsibilities- Develop and execute the Safety Surveillance and Risk Management strategy for assigned therapeutic areas, ensuring compliance with global legislation and regulations.
- Lead a team of Medical Directors and Safety Scientists in identifying, evaluating, and facilitating resolution of safety signals, including effective communication of risk management plans.
- Provide medical and pharmacovigilance expertise to oversee and lead decision-making based on complex risk/benefit evaluation, pharmacoepidemiological or clinical trial data interpretation, risk assessment, and risk mitigation.
- Partner with internal leaders within Global Patient Safety and other Mymenopauserx, Llc functions and affiliates to deliver integrated pharmacovigilance and risk management support to the business.
- Lead Product Safety Management Teams with Medical Directors to support key decision-making, drive evidence-based conclusions, and develop pivotal next steps.
- Oversee work carried out on products and/or issues under highest scrutiny from a patient safety or regulatory perspective.
- Ensure ongoing and adequate safety surveillance, and timely detection and communication of new safety issues by the team.
- Ensure timely and adequate generation of aggregate reports, regulatory responses, and risk management documentation by the team, according to international requirements and internal standards.
- Proven experience in leading global patient safety and risk management efforts.
- Strong understanding of global legislation and regulations related to patient safety and pharmacovigilance.
- Excellent leadership and communication skills.
- Ability to work effectively in a fast-paced environment and prioritize multiple tasks and projects.
- Strong analytical and problem-solving skills.
- Ability to collaborate with cross-functional teams and stakeholders.
