Senior Medical Director, Pharmacovigilance

Your role:

• Chair Safety Management Team for assigned products at Merus
• Lead product safety surveillance, and signaling activities for assigned product(s) in collaboration with Pharmacovigilance staff, to include the following:
  • Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile including a working knowledge of other products in the class and therapeutic space
  • Design, implement and ensure routine signaling activities, assessments and investigations are effectively completed and documented in a timely manner
  • Respond to product safety queries from all sources including ethics committees and regulatory authorities
• Lead product benefit-risk assessment and presentation to the Safety Management Team and Executive Safety Committee and any needed actions, for example, IB update, update to patient safety information, or modifications to protocols
• Lead Pharmacovigilance representation in the assigned program team and clinical development team and respective study management teams with critical roles which include:
  • Strategic advisement on clinical development plans, design of clinical protocols
  • Responsible for safety content of IB and ICFs and support of DSMBs
  • Analysis strategy for Integrated Summary of Safety (ISS) and benefit-risk content within the Clinical Overview documents associated with regulatory filings
  • Content of Risk Management Plan/ REMS (as required)
  • Advisement on the design of post-approval safety studies
• It is expected that the global safety officer will establish a high level of trust and collaboration with cross-functional counterparts in carrying out these activities
• Ensure development and implementation of other department goals, policies and strategies in collaboration with the VP Pharmacovigilance, consistent with regulatory requirements and industry best practices
• Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal timeframes and timeframes dictated by regulatory authorities
• Other job duties that may be assigned according to business needs

Your profile:

• MD, or MD PhD, or MD MPH required
• Minimum 8-10 years of PV MD experience within the biotechnology or pharmaceutical industry is required
• Strong background and previous experience in Product Safety/Safety Management Team (or similar model) lead (PST/SMT Lead) with strategy oversight is preferred
• Prior experience in patient care, clinical development and/or knowledge of clinical pharmacology desirable
• High EQ with demonstrated skills and experience fostering a positive culture within a PV organization
• Expert knowledge of global PV requirements, e.g. US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines
• Experience and extensive working knowledge of individual case medical review, signal detection and evaluation, and clinical study safety management
• Experience with the compilation, writing and reviewing of safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels
• Experience with audits and inspection
• Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization
• Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail

Our offer