We are seeking an experienced and highly motivated Medical Director, Drug Safety to lead global drug safety activities for our innovative portfolio in immunology and rare diseases. This role is ideal for a qualified Medic (MD or equivalent) with a strong background in pharmacovigilance and clinical development, who thrives in a dynamic, cross-functional, and international environment.
There will be required travel to the office in Belgium
Key Responsibilities:
* Provide medical and scientific leadership for global pharmacovigilance activities across the product lifecycle (pre- and post-marketing).
* Lead safety surveillance and signal detection activities for assigned products, ensuring timely identification and communication of safety issues.
* Serve as the medical safety expert on cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs.
* Author and review key safety documents including DSURs, PSURs/PBRERs, RMPs, and investigator brochures.
* Contribute to the development and maintenance of risk management strategies and benefit-risk assessments.
* Participate in regulatory interactions and inspections, providing expert input on safety-related matters.
* Support clinical trial safety monitoring, including medical review of SAEs, and provide input into protocols and informed consent forms.
* Mentor and guide junior safety physicians and scientists.
Qualifications:
* Medical degree (MD or equivalent) is required.
* Minimum of 7 years of experience in pharmacovigilance/drug safety, with at least 3 years in a leadership role.
* Strong knowledge of global regulatory requirements (e.g., FDA, EMA, ICH) related to drug safety.
* Experience in immunology and/or rare diseases is highly desirable.
* Proven ability to analyze complex safety data and make sound medical decisions.
* Excellent communication, leadership, and cross-functional collaboration skills.
* Ability to work effectively in a global, matrixed environment.