VP – Head of Safety and Pharmacovigilance

VP – Head of Safety and Pharmacovigilance

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Merus is seeking an innovative and collaborative leader to join our team as the Vice President, Head of Safety and Pharmacovigilance.  

This role is pivotal in ensuring that Merus remains a leader in patient safety and pharmacovigilance, fostering a culture where safety is integrated into every aspect of our drug development process. Reporting directly to the Chief Medical Officer (CMO), you will be leading and building out the Merus’s PV and risk management function. This includes being responsible for the strategic oversight and execution of all safety and pharmacovigilance activities, ensuring compliance with global regulatory standards. 

The Role

As the VP, Head of Safety and Pharmacovigilance, you will lead Merus’ efforts in ensuring the safety of our investigational products. This involves providing strategic medical oversight, managing safety data, and guiding cross-functional collaboration to integrate safety into all phases of our product lifecycle. As Merus is building out it’s PV department anew, you will be responsible for creating and building the Safety and Risk Management function.  Your role will include interacting with regulatory authorities, leading the pharmacovigilance team, and overseeing the activities of external safety service providers.

Key Responsibilities: 

  • Lead and build Merus’s PV and Risk Management function 
  • Establish and maintain a safety and pharmacovigilance infrastructure that prioritizes “safety by design” in all development activities. 
  • Lead all pharmacovigilance and risk management activities for Merus products, including safety surveillance, signal detection, and risk-benefit assessments. 
  • Serve as the primary contact for safety-related issues, including regulatory authority interactions and safety service provider management. 
  • Provide strategic safety insights to the CMO and Executive Leadership Team, particularly regarding the risk-benefit profile of company products. 
  • Oversee the preparation and review of safety documents, including DSURs, safety reports, and clinical development documentation. 
  • Ensure compliance with global safety regulations and guidelines, and lead responses to safety-related inquiries from regulatory authorities. 
  • Manage the pharmacovigilance budget and resources, including both internal teams and external contractors. 
  • Drive continuous improvement in pharmacovigilance practices, ensuring readiness for regulatory inspections and audits. 
  • Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Quality, to integrate safety considerations into company strategy. 
  • Represent Merus externally, building relationships with industry leaders and vendors to enhance our safety and pharmacovigilance capabilities. 

Your Profile

The ideal candidate for this role will have a proven track record of leadership in pharmacovigilance, coupled with deep expertise in global safety regulations. You will be a strategic thinker with a strong ability to collaborate across functions and lead a team toward continuous improvement.

Qualifications: 

  • M.D., D.O., or M.B.B.S. required. 
  • Minimum of 10 years of global experience in drug safety within the biotechnology or pharmaceutical industry. 
  • In-depth knowledge of FDA safety regulations, ICH Guidelines, EU GVP, and other global safety regulations. 
  • Deep understanding of risks and risk mitigation steps related to safety signals and pharmacovigilance 
  • Expert knowledge of safety database applications (e.g., ARGUS, ARISg) and safety signal detection. 
  • Strong leadership skills with the ability to mentor teams and lead cross-functional initiatives. 
  • Excellent written, verbal, and presentation skills, with the ability to influence senior leadership and external stakeholders. 

Why Merus?

At Merus, we are committed to creating a dynamic and supportive environment where innovation thrives. As a senior leader, you will play a key role in shaping the future of our company, ensuring the safety of our patients and driving our mission forward. Join us and be part of a team that is making a difference in the lives of patients worldwide. 

Apply now

    Our Hiring Process

    Stage 1:

    Internal Review

    This means that we’ve received your application and are in the process of reviewing it.

    Stage 2:

    Initial Call

    We’ll set up a 15-minute phone call with our Internal Recruiter to discuss the details of this job opportunity and your own expectations of the role, as well as Merus as a company.

    Stage 3:

    1st Interview Phase

    During the 1st interview phase, we’ll set up an interview with your potential future manager. We’ll be looking to understand more about your experience, how that fits the role, and what makes you tick.

    Stage 4:

    2nd Interview Phase

    If things are still looking good, we’ll set up several short interviews with team members, peers, Management Team members (where relevant) and HR to make sure we are a good cultural fit. We do our best to plan these interviews on the same day, although on rare occasions they’ll take place on multiple days.

    Stage 5:

    Job Offer

    After positive evaluation from both sides, you will receive our job offer. Once you’ve accepted it, we will draw up the necessary paperwork. You will receive your contract within 3-5 working days and your onboarding process will start!

    Stage 6:

    Welcome

    We’re more than happy to welcome you to join Merus in our pursuit to close in on cancer!

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