Medical Director, Medical Safety

Essential Functions

• Lead the preparation and review of safety-related section(s) for product/s. Documents include review of specific clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical plans, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents as needed, ensuring safety profile reflected for assigned product/s.
• Be a key member, as the safety representative, to a Global Regulatory Team and to a Core Development Team.
• Interface with Risk Evaluation and Mitigation Strategy (REMS) team to optimize risk management of assigned products from a PV perspective.
• Where relevant, support creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling.
• Support review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned product/s, as needed.
• Support signal detection activities to ensure signal identification, evaluation, validation, for assigned product including individual and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with CRSO and PV management.
• Contribute to the preparation and review of pre- and post- marketing aggregate safety reports IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports and ensure consistent communication of safety profile/topics across various regulatory safety documents for assigned product/s.
• Contribute to preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements.
• Provide guidance with adverse event (MedDRA) and drug (WHO Drug) coding for clinical and postmarketing safety data.
• Demonstrate or gain knowledge of current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), SOPs and quality standards.
• Provide safety expertise to due diligence activities, if/ as needed.
• Keeps abreast of new PV/safety regulations and guidance from the regulatory authorities.

Required Knowledge, Skills, and Abilities

• Minimum 2-5 years of Clinical Development, Medical Affairs or Drug Safety/Pharmacovigilance experience; other relevant medical affairs experience may be considered.
• Excellent knowledge of drug development process.
• Requires a high level of initiative and independence.
• Must have excellent written and oral communication skills, resourcefulness and personal organization skills together with demonstrated cross-functional teamwork.
• Computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word.
• Some national/international travel may be required.

Leadership Skills

• Enterprise and Proactive Mindset—demonstrate collaborative spirit, understanding the benefit of working with others cross functionally, in a dynamic environment.
• Set & Achieve Goals: Understand business objectives and effectively translate them into strategies, while skillfully navigating obstacles and resistance to change.
• Inspire & Mobilize Others: Serve as a positive role model – create followership and effectively mobilize and influence others, both on your teams and across the organization.

Required/Preferred Education and Licenses

• MD required; medical licensure in at least one region preferred; clinical research and/or fellowship training in internal medicine, oncology, neurology, or other relevant specialty is a plus.