VP, Global Head of Drug Safety and Pharmacovigilance

Position Summary:

The Global Head of PV will be required to collaborate within the PV department and cross-functionally to build and implement process and framework strategies for a robust, globally compliant, and inspection-ready department. This role requires a hands-on leader with deep operational expertise, a strong understanding of global regulatory requirements, and the ability to design and oversee a fit-for-purpose safety system that meets both development and post-marketing needs. The ideal candidate will be a healthcare professional (e.g., MD/DO, PharmD, RN, or equivalent) with broad experience across case management, aggregate reporting, signal detection, labeling, and inspection readiness.  Prior experience as a Head of PV is a requirement. 

Key Responsibilities:

• Build and oversee the PV system and ensure alignment with FDA, EMA, MHRA, PMDA, and ICH requirements in conjunction with the Senior Director of PV Operations.
• Ensure medical oversight of the PV function including medical review of all cases inclusive of case narratives and causality assessments of AE/SAE reports.
• Create and maintain a signal detection process (including regular and ad hoc reviews of aggregate safety data).
• Coordinate safety governance within the company and ensure cross-functional involvement in the evaluation of potential emerging safety issues and any associated risk mitigation and management measures that are proposed.
• Participate as a key stakeholder in safety analyses and ensure proactive and timely benefit-risk assessments of safety data.
• Represent PV in communication with health and regulatory authorities including management of the DSUR process and being signatory for DSUR, PAER and other safety reports to FDA and other health authorities
• Represent Zenas at Independent Data Safety Monitoring Committee meetings.
• Design and implementation of any necessary Risk Management plans
• Compile analysis of adverse events of special interest (AESI), individual case comments, risk management plan implementation, and ad hoc safety analysis as required by health authorities or corporate policy.
• Serve as SME author, reviewer, and approver for drug-safety related regulatory reports and clinical study documents (including Clinical Study Protocols, Informed Consent Forms, Investigator Brochures, Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE), product package labeling, Company Core Safety Information, etc).
• Effective interpersonal, communication and influencing skills, including excellent writing skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems.
• Strong learning orientation, curiosity, and commitment to science and patients.
• Lead, supervise and mentor a high performing PV function
• Develop operating plans and budgets and allocate resources to ensure budgets, schedules, and performance requirements are met.
• Partner cross-functionally with Clinical Development, Regulatory, Quality, and Medical Affairs to ensure safety considerations are integrated across the product lifecycle.
• Establish and maintain the global safety database, case processing workflows, and vendor oversight.
• Prepare the organization for post-approval PV obligations, including surveillance, literature monitoring, and signal management.
• Develop Standard Operating Procedures (SOPs) and ensure inspection readiness for FDA/EMA inspections.
• Provide PV input to promotional review committees and commercial launch planning.
• Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools and other sources of product signals.
• Escalate as appropriate and coordinate ongoing evaluation of the safety profile across products in concert with cross-functional colleagues.
• Responsible for finalizing and ensuring safety data exchange agreements with partners are robust and complied with.
• Lead the safety strategy for regulatory communications regarding the benefit-risk profile across products.

Qualifications:

• MD/DO, PharmD, RN, or equivalent required
• 15+ years PV experience which includes working with developmental/investigational products and with prior experience as a head of PV.
• Proven track record in leadership roles and management.
• Demonstrated expert knowledge of relevant FDA, EMA, Asia-PAC, ICH guidelines and regulations.
• Robust knowledge of MedDRA dictionary with relevance to analysis and coding.
• Experience communicating safety information to internal and external stakeholders, including agency interactions
• Experience with registrational submissions with FDA and EMA

#LI-Hybrid

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $$308,000 to $385,000.  Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.