Pharmacovigilance Scientist (Director – Senior Director)

Your role:

• Leads PV Scientist activities of cross-functional project teams for developmental compounds and/or marketed products at Merus.
• Works in collaboration with the Global Safety Physician to develop, maintain, oversee, and execute the comprehensive safety surveillance and signal detection plan for assigned products. 
• Author and contribute safety sections and other relevant content to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Leads the collaboration with Safety and Clinical representatives, and authors the Reference Safety Information (RSI) for assigned products based on the developed benefit-risk profile.
• Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to processes and timelines.
• Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the Global Safety Physician and other functional experts.
• Contributes to pharmacovigilance and risk management planning for Merus products, including preparation of the safety aspects of Risk Management Plans with the applicable License Partners as appropriate and REMS if applicable.
• Supports multidisciplinary Safety Management Team and escalation of all relevant safety matters to the appropriate decision-making level, providing appropriate proposals for solutions based on analysis of the available information and in collaboration with the Global Safety Physician.
• Additional projects as assigned
• Participates in PV audits, inspections, CAPA activities as required
• Contributes to drug safety departmental policies and procedures that address signal detection and management, safety governance, and periodic reporting as applicable.

Your profile:

• Bachelor’s in sciences/pharmacy/nursing degree or related field Bachelor’s degree in health-care related discipline or equivalent, RN, R.Ph., or Pharm D. degree is highly preferred
• 8+ years of proven pharmacovigilance experience preferably in oncology
• Experience working in safety &/or scientific activities in the setting of Product Safety Team/Safety Management Team model
• Experience with Early and Late Phase development clinical trials and safety surveillance  and signal detection processes
• High EQ with demonstrated skills and experience fostering a positive culture within a PV organization
•  General knowledge and understanding of US and EU 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 MedDRA and proprietary safety databases, PV processes for individual case medical review, signal detection and evaluation, aggregate data assembly, review and reporting, as well as 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
• Previous MAA/BLA experience including contributing to the preparation and authoring of the safety related aspects of the Common Technical Document
• 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