Global Safety Associate Medical Director

As the Global Safety Officer (GSO) for Marketed Products, you play a crucial role in ensuring the safety and well-being of the assigned marketed products. Your responsibilities include establishing the strategy, direction, and priorities of pharmacovigilance activities related to the assigned products. You are also accountable for overseeing the overall safety profile, making product-related decisions, and delivering on all associated responsibilities. - Developing and maintaining core reference safety information - Conducting benefit-risk evaluations - Participating in the product label process - Developing strategies for clinical trial safety - Leading responses to safety-related inquiries from regulatory agencies - Performing signal detection activities - Evaluating safety signals and determining further analysis strategies - Developing risk management plans - Ensuring timely preparation of periodic safety reports - Participating in safety governance meetings - Representing Global Patient Safety in commercialization processes - Undertaking activities for inspection readiness - Participating in safety agreement development and review process - Interacting with external stakeholders on safety-related topics - Providing safety input to support legal needs - Overseeing day-to-day activities of the Global Safety Physician (if applicable) - Providing training, coaching, mentoring, and development of staff - Assisting in the recruitment of talented personnel - Disseminating and representing corporate and departmental information to staff The ideal candidate for this position should hold a Medical Degree (MBBS or MD) from an accredited medical school and have a minimum of 8 years of relevant experience in product safety within the bio/pharmaceutical industry, CRO, or regulatory agency. Previous management and/or mentoring experience, as well as clinical/medical research experience, are preferred qualifications.,