Pharmacovigilance Operations

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 Director, Pharmacovigilance (PV) Operations who will implement and coordinate PV department procedures at Merus, provide strategic direction and oversight of day-to-day operations, and ensure compliance with adverse event collection and reporting requirements. This role will also be responsible for the operational management and oversight of case processing activities performed externally by vendors, working across internal stakeholders to contribute PV support to clinical trials, contributing to case management database strategy, and quality and compliance including inspection readiness and training. In this role you will:

• Provide effective vendor management strategies for PV for both pre and post market products
• Manage all PV vendor related activities including scope of work, safety management plans, contracts, training, and oversight of outsourced case processing work
• Support and oversee all vendor activity related to individual case safety reports (ICSR), aggregate reports (DSUR, PSUR, and PADERs), compliance metrics, and expedited reporting
• Serve as lead for Quality and Compliance within PV and ensure PV department inspection readiness
• Provide PV Operational support to clinical trial study teams including the development and review of core safety documents such as ICFs, IBs, protocols, and supporting other study activities such as SAE reconciliations and authoring safety sections of clinical study reports
• Work closely with cross-functional teams, including Regulatory Affairs, Clinical Operations, and Medical Affairs, to maintain robust pharmacovigilance practices in line with global regulatory standards
• Contribute to PV agreements with license partners and/or other parties as required, and support such alliances from operational perspective
• Operationally support signal detection, aggregate report preparation and safety labeling updates
• Support the preparation and review of the safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, IND/NDA/BLA/MAA and other regulatory submissions
• Serve as PV lead for escalation and investigation of safety and non-compliance issues and identifies root causes for late ICSR submissions and the implementation of appropriate corrective actions, as needed
• Manage the creation and the periodic review of PV procedural documents such as SOPs to support pre and post market products
• Ensure awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies and SOP
• Provide PV guidance and support for interdepartmental and/or corporate initiatives
• Participates in the development and management of departmental budget planning

Skills, Knowledge and Expertise

Your profile: We are looking for a candidate with:

• Bachelor’s degree in science area, pharmacy, nursing, or a related field
• Minimum of 8 years of experience in pharmacovigilance, drug safety, or a related role within the pharmaceutical/biotech industry
• Minimum of 4 years managing PV vendors
• In-depth knowledge of global pharmacovigilance regulations (FDA, EMA, ICH, GVP)
• Proficiency with safety databases (e.g., Argus, ArisG) and coding dictionaries (MedDRA, WHO-DD)
• Knowledge of pre and post marketing PV regulations including GVP regulations
• Demonstrated track record of experience and successfully managing business process outsourcing vendors and relationships
• Highly innovative and self-motivated, with excellent time management and organizational skills
• Ability to proactively assess department risk related to process/procedure and provide remediation
• Experience with quality and compliance function within PV, including inspection readiness strategy development and implementation, and previous inspection experience required
• Experience with reviewing of safety documents such as DSURs, IB, PBRERs/PADERs
• Ability to work collaboratively with cross-functional teams
• Experience with signal detection and risk management tools is a plus
• Proficient with Microsoft Office

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.