Executive Director, Pharmacovigilance Strategy

Executive Director, Pharmacovigilance Strategy Job Type: Full-time Department: Business Development PrimeVigilance (part of Ergomed PLC) is a specialised mid-size pharmacovigilance service provider established in 2008. We have achieved consistent global growth, with staff across Europe, North America, and Asia, offering services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We support pharmaceutical and biotechnology partners of all sizes, maintaining long-term relationships and becoming a global leader in our field. Our coverage spans all therapy areas, including medical devices. We invest in our staff through excellent training and development, valuing employee experience, well-being, and mental health. We believe a healthy work-life balance is key to employee satisfaction and high-quality client service. Join us in making a positive impact on patients\’ lives. Role Overview The Executive Director, PV Strategy is a senior pharmacovigilance expert with deep knowledge of PV regulations, leadership, and communication skills. This role provides scientific and medical support throughout the product lifecycle, including authoring and reviewing complex PV and regulatory documents, and advising on PV processes and strategies. The role may also serve as the EU/UK Qualified Person Responsible for Pharmacovigilance (QPPV). Key Responsibilities Assuming the role of EU/UK QPPV or deputy Providing expert advice on all areas of pharmacovigilance Authoring and reviewing PV procedural documents Collaborating with PrimeVigilance departments to optimize PV processes Participating in audits and inspections Performing gap analyses of PV systems Supporting internal initiatives across departments Providing PV consultancy services as per contractual agreements Preparing and delivering advanced PV training internally and for clients Representing the company at international PV congresses and conferences Supporting business development and marketing activities (e.g., creating collateral, writing articles, webinars) Staying updated on PV legislation and advising on regulatory compliance Contributing to technological improvements within the company Providing leadership, guidance, and mentorship to junior staff Preparing and delivering complex client PV reports, presentations, and regulatory documents Advising clients on PV regulatory requirements and strategies Qualifications University degree in a life sciences subject Extensive experience in pharmacovigilance, including as EU or UK QPPV for complex PV systems Experience with PV inspections Experience in PV-related business development Experience presenting at international PV events Line management experience (desirable) Strong communication, presentation, and leadership skills Fluent in English; additional languages are a plus Additional Information We prioritize diversity, equity, and inclusion, fostering an environment where all backgrounds, genders, and ages can contribute and grow. We believe in working together with a human-first approach, valuing our people as our greatest strength. We offer: Internal training and career development Focus on personal and professional growth Supportive, friendly work environment Global collaboration opportunities, primarily in English Our core values are: Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging. If these resonate with you, PrimeVigilance could be a great place to join! We look forward to your application. #J-18808-Ljbffr