Pharmacovigilance Scientist

Company Overview

At Merus we are advancing leadingedge 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 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

• Leads PV Scientist activities of crossfunctional 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 benefitrisk 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 decisionmaking 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.
  
  

Skills Knowledge and Expertise

Your Profile

We are looking for a candidate with:

• Bachelor’s in sciences/pharmacy/nursing degree or related field Bachelor’s degree in healthcare 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
  
  

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.