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# Head of Drug Safety – Pharmacovigilance


Role Overview for Head of Drug Safety & Medication Safety Surveillance
JRG Partners, a premier executive search firm specializing in the life sciences and pharmaceutical sectors, is delighted to partner with a rapidly expanding, innovative biopharmaceutical company in their search for a visionary and highly experienced Head of Drug Safety & Pharmacovigilance.
This is a pivotal leadership role demanding an individual with a profound understanding of global pharmacovigilance systems, an unwavering commitment to patient safety, and exceptional strategic acumen in regulatory compliance. As the Head of Drug Safety & Pharmacovigilance, you will be instrumental in shaping and leading the company’s global pharmacovigilance strategy, ensuring the highest standards of safety monitoring for all marketed and investigational products.
The successful candidate will be a key member of the senior leadership team, responsible for building, optimizing, and overseeing a world-class pharmacovigilance function. This role offers a unique opportunity to make a significant impact on patient outcomes, drive regulatory excellence, and contribute directly to the company’s mission of bringing life-changing therapies to patients worldwide.
You will lead a dedicated team of PV professionals, foster a culture of vigilance and compliance, and serve as the primary expert on all drug safety matters within the organization. This position requires not only deep technical expertise but also strong leadership capabilities, cross-functional collaboration skills, and the ability to navigate complex global regulatory landscapes effectively. If you are a seasoned PV leader passionate about patient safety and ready to drive strategic initiatives in a dynamic environment, we encourage you to explore this exceptional opportunity.
Key Responsibilities of Head of Drug Safety & Pharmacovigilance
The Head of Drug Safety & Pharmacovigilance will be entrusted with a comprehensive range of responsibilities critical to ensuring the safety and regulatory compliance of all company products. These responsibilities are designed to establish and maintain a robust, efficient, and compliant global pharmacovigilance system. Your duties will include, but are not limited to, the following:
Strategic Leadership & Oversight
Develop, implement, and continuously refine the global pharmacovigilance strategy, policies, and procedures in alignment with corporate objectives and evolving global pharmacovigilance regulations. Provide strategic direction and leadership for all drug safety and pharmacovigilance activities across the product lifecycle, from clinical development through post-marketing surveillance.
Regulatory Compliance
Ensure strict adherence to all applicable international and national pharmacovigilance regulations and guidelines, including those from the FDA, European Medicines Agency (EMA), ICH E2B/E2C/E2D/E2F, GVP modules, CIOMS, and other relevant regulatory bodies. Stay abreast of changes in global PV regulations and proactively implement necessary adjustments to internal processes and systems.
Safety Signal Detection & Risk Management
Oversee the comprehensive process of safety signal detection, evaluation, and management for all products. Develop and implement robust risk management plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) as required, ensuring proactive identification and mitigation of potential safety concerns.
Adverse Event Case Processing
Ensure the timely, accurate, and consistent processing, coding, and reporting of individual case safety reports (ICSRs) from all sources (clinical trials, post-marketing, literature, solicited programs) to regulatory authorities worldwide within mandated timelines.
Aggregate Report Generation
Direct the preparation, review, and submission of all aggregate safety reports, including Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), and other ad-hoc safety reports to global health authorities.
Inspection Readiness & Management
Lead all pharmacovigilance inspection readiness activities, including internal audits and external regulatory inspections. Serve as the primary contact and subject matter expert during regulatory inspections and audits, ensuring successful outcomes and timely remediation of any findings.
Quality Management System
Establish and maintain a comprehensive Pharmacovigilance Quality Management System (PV QMS), including Standard Operating Procedures (SOPs), Work Instructions (WIs), and Quality Agreements, ensuring continuous improvement and compliance.
Team Leadership & Development
Recruit, mentor, train, and manage a high-performing team of pharmacovigilance professionals. Foster a collaborative and engaging work environment that encourages professional growth, accountability, and a patient-centric mindset.
Cross-Functional Collaboration
Collaborate effectively with internal departments such as Clinical Development, Regulatory Affairs, Medical Affairs, Quality Assurance, Commercial, and Legal to ensure seamless integration of safety activities and timely exchange of safety information.
Vendor Oversight
Manage and oversee relationships with external vendors, Contract Research Organizations (CROs), and business partners involved in pharmacovigilance activities, ensuring compliance with contractual obligations and regulatory requirements.
Safety Data Exchange Agreements (SDEAs)
Develop, implement, and monitor SDEAs with partners, ensuring compliance with all terms and conditions related to safety data exchange.
Budget Management
Develop and manage the pharmacovigilance department’s budget, optimizing resource allocation and ensuring cost-effective operations while maintaining high quality and compliance standards.
Training & Education
Develop and deliver comprehensive pharmacovigilance training programs for internal staff and relevant external stakeholders to ensure awareness and compliance with PV responsibilities.
Requirements for the Head of Drug Safety & Medication Safety Surveillance
To excel in this critical leadership role, candidates must possess a unique blend of extensive industry experience, deep scientific knowledge, exceptional leadership qualities, and a proven track record in global pharmacovigilance. We are seeking a dynamic leader who can not only manage complex operations but also strategically guide the company’s approach to drug safety in an evolving regulatory landscape.
Education
An advanced degree is required. This typically includes an MD (Medical Doctor), PharmD (Doctor of Pharmacy), or PhD in a health-related scientific discipline (e.g., Epidemiology, Pharmacology, Toxicology, Public Health).
Experience
A minimum of 15 years of progressive experience in pharmacovigilance within the pharmaceutical or biotechnology industry is essential. This must include at least 8-10 years in a leadership role overseeing global pharmacovigilance operations, managing teams, and interacting with senior leadership and regulatory authorities.
Regulatory Expertise
In-depth, hands-on knowledge and practical application of global pharmacovigilance regulations, guidelines, and best practices (e.g., FDA, EMA GVP modules, ICH E2 series, CIOMS, MHRA, PMDA). Demonstrated ability to interpret complex regulations and translate them into actionable internal processes.
Leadership & Management Skills
Proven ability to build, lead, mentor, and motivate high-performing pharmacovigilance teams. Experience in fostering a culture of accountability, continuous improvement, and professional development. Strong change management skills are highly valued.
Strategic Acumen
Demonstrated ability to develop and execute comprehensive, forward-thinking PV strategies that align with business objectives, anticipating future regulatory trends and industry challenges.
Communication & Interpersonal Skills
Excellent written and verbal communication skills, with the ability to present complex scientific and regulatory information clearly, concisely, and persuasively to diverse audiences, including senior executives, regulatory authorities, and external partners.
Analytical & Problem-Solving Skills
Strong analytical capabilities with extensive experience in safety signal detection, risk assessment, root cause analysis, and the development of effective mitigation strategies. Ability to make sound, data-driven decisions under pressure.
Safety Database Experience
Proficient in the use of industry-standard safety databases (e.g., Argus, ArisG, Oracle Siebel, Veeva Safety) and electronic document management systems.
Cross-functional Collaboration
Demonstrated ability to work collaboratively and influence effectively across various functional areas (Clinical Development, Regulatory Affairs, Medical Affairs, Quality Assurance) to achieve common goals.
Inspection & Audit Experience
Extensive experience in preparing for and successfully managing regulatory inspections and internal/external audits related to pharmacovigilance.
Global Mindset
Experience working in a global environment, managing diverse teams, and understanding regional nuances in pharmacovigilance practices.
Project Management
Strong organizational skills, attention to detail, and the ability to manage multiple priorities and complex projects simultaneously in a fast-paced, evolving environment.
Benefits & Perks Offered
Our client values its employees as their most vital asset and is committed to providing a comprehensive and competitive benefits package designed to support the well-being, financial security, and professional growth of its team members. As the Head of Drug Safety & Pharmacovigilance, you will be eligible for a suite of outstanding benefits and perks, reflecting the strategic importance of this role within the organization. These include:
Highly Competitive Compensation
An attractive base salary commensurate with experience and industry standards, complemented by a performance-based annual bonus program.
Comprehensive Health & Wellness
Robust medical, dental, and vision insurance plans for you and your family, with options for PPO and HMO coverage, prescription drug benefits, and wellness programs.
Financial Security
A generous 401(k) retirement savings plan with a substantial company match, ensuring your long-term financial stability. Life insurance, short-term and long-term disability coverage are also provided.
Generous Paid Time Off (PTO)
Ample vacation, sick leave, and paid holidays, allowing for a healthy work-life balance and personal rejuvenation.
Flexible Work Arrangements
The company embraces modern work models, offering flexible work options, including remote-first capabilities for this role, to support productivity and personal commitments.
Professional Development
Significant investment in your career growth through opportunities for continuing education, industry conference attendance, leadership training programs, and professional certifications.
Employee Assistance Program (EAP)
Confidential resources and support for personal and work-related challenges.
Innovative Culture
Join a dynamic, collaborative, and patient-focused work environment where your contributions are highly valued and directly impact global health.
Impactful Work
The opportunity to lead a critical function that directly contributes to patient safety and the successful development and commercialization of life-changing therapies.
Modern Technology & Resources
Access to cutting-edge tools, technologies, and resources to support your work and enhance efficiency.
Company-Sponsored Events
Regular team-building activities, social events, and company gatherings (virtual and in-person) to foster a strong sense of community.
How to Apply
If you are a distinguished Pharmacovigilance leader with a passion for patient safety and a proven track record of strategic leadership in the biopharmaceutical industry, we invite you to connect with JRG Partners. This is an unparalleled opportunity to guide a critical function within a forward-thinking company dedicated to scientific innovation and improving human health.
To express your interest in this Head of Drug Safety & Pharmacovigilance position, please submit your comprehensive resume and a compelling cover letter outlining your relevant experience, leadership philosophy, and vision for pharmacovigilance excellence. Please ensure your application clearly highlights how your qualifications align with the requirements of this role.
Submit your application through our secure online portal. For more information on how JRG Partners empowers careers in the life sciences and pharmaceutical sectors, please visit our dedicated Life Sciences Practice page. Our expert recruiters are ready to discuss this exceptional opportunity with qualified candidates in strict confidence.
JRG Partners is an equal opportunity employer and values diversity. All employment decisions are based on qualifications, merit, and business need. We encourage all qualified candidates to apply.