Senior Global Program Safety Team Lead

hace 4 semanas


Barcelona, Barcelona, España Advanced Accelerator Applications (Italy) - S... A tiempo completo
About the Role

Are you ready to lead the charge in improving patients' lives and driving impactful results at Advanced Accelerator Applications? As the Senior Global Program Safety Team Lead, you will be at the forefront of our Medical Safety organization, ensuring robust safety risk management and making a positive impact on our development programs.

Key Responsibilities:

• Manage an efficient and successful disease area within the TA/DU Medical Safety organization, providing robust medical and science-driven contribution to Benefit-Risk evaluation throughout product lifecycle to enable Advanced Accelerator Applications to provide impactful medicines to patients worldwide.

• Enhance scientific and clinical experience of Medical Safety physicians/scientists through continuous training and coaching.

• Prepare safety objectives and evaluate and manage performance of the Medical Safety associates within the TA/DU.

• Lead the day-to-day safety activities and provide guidance to assigned Medical Safety team members and mentee(s), as well as to direct reports.

• Mentor junior CMO and Patient Safety personnel. Proactively engage in the development of competencies across the Medical Safety Function.

• Provide expert safety input to the clinical development program, in particular for heavyweight/high-profile projects/products; be an active member of the Global Program Team (GPT), Global Clinical Team (GCT), and Clinical Trial Team (CTT).

• Responsible for safety issue management from formation of GPT through Life Cycle Management.

• Develop and be responsible for key internal Advanced Accelerator Applications safety documents, review these documents regularly, and update as required (e.g., when significant new information received).

• Own the safety strategy and document it appropriately (e.g., dSPP, SSPT); lead the production of medical safety deliverables (e.g., DSUR, PSUR, RMP) for the assigned products.

• Responsible for overall signal detection, monitoring, evaluation, interpretation, and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources. To this end, constitute and run the Safety Management Team (SMT). Ensure that this team appropriately and timely reviews all medical safety data from various sources (e.g.,

What We Offer

As a Senior Global Program Safety Team Lead, you will have the opportunity to work on impactful projects, develop your skills, and contribute to the success of Advanced Accelerator Applications. We offer a dynamic and supportive work environment, competitive compensation, and opportunities for growth and development.

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