Pharmacovigilance Scientist

At Merus, we are advancing leading-edge, targeted treatments using our pioneering multispecific antibody generating technologies, Multiclonics®, to address the unmet needs of patients with various types of cancer. Working at Merus gives you the opportunity to contribute to our mission of closing in on cancer. We care deeply about improving patients’ lives. This is why we are committed to getting this right, with a global and diverse team of highly qualified professionals. We have bold aspirations because the need is great, and the patients are waiting. Join us and make an impact. 😊

Key Responsibilities

Your role: Merus is seeking a Sr/Director, Pharmacovigilance (PV) Scientist who will be accountable for overall PV science support for the pharmacovigilance department at Merus, which includes working in collaboration with the Global Safety Physician(s) to lead signal detection activities conducted in the safety governance model within the company. This includes review of adverse event and laboratory data as applicable, Serious Adverse Events reported in clinical trials, and literature relevant to the products assigned. The ideal candidate will play a critical role in further developing and enhancing PV processes and procedures relative to the PV scientist role. The position reports to the VP of Pharmacovigilance/Head of Safety and is remote based but will be affiliated with the Cambridge, MA office location and will be expected to travel to the office as needed for meetings and other business needs. In this role you will:

• Lead PV Scientist activities of cross-functional project teams for developmental compounds and/or marketed products at Merus.
• Work 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.
• Lead the collaboration with Safety and Clinical representatives, and author the Reference Safety Information (RSI) for assigned products based on the developed benefit-risk profile.
• Author/provide strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to processes and timelines.
• Author/provide 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.
• Contribute 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.
• Support 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.
• Participate in PV audits, inspections, CAPA activities as required.
• Contribute to drug safety departmental policies and procedures that address signal detection and management, safety governance, and periodic reporting as applicable.
• Additional projects as assigned.

Skills, Knowledge and Expertise

Your profile: We are looking for a candidate with:

• 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 the ability to interact effectively in a multifunctional, multicultural, growing organization.
• Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, and written communication skills, attention to detail.

Benefits

Our offer: We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you’ll have the chance to help us close in on cancer – everything you do matters at Merus.