Executive Director, Pharmacovigilance Strategy
Full-time
Department: Business Development
We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We pride ourselves on achieving global organic growth year after year, with staff across Europe, North America, and Asia, covering services within Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
PrimeVigilance provides top-tier support to our pharmaceutical and biotechnology partners, maintaining long-lasting relationships and becoming one of the global leaders in its field. We cover all therapy areas, including medical devices.
We invest in our staff by offering excellent training and development opportunities. We value employee experience, well-being, and mental health, recognizing that a healthy work-life balance is crucial for employee satisfaction and high-quality client service.
Join us on this exciting journey to make a positive impact on patients' lives.
Role Overview
The Executive Director, PV Strategy, is a senior expert in pharmacovigilance with a deep understanding of PV regulations, effective 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 Executive Director may act as the European Union/United Kingdom Qualified Person Responsible for Pharmacovigilance (QPPV) and provide expert advice across all PV areas.
Key Responsibilities
1. Assume the role of EU/UK QPPV or deputy
2. Provide expert advice on pharmacovigilance
3. Author and review PV procedural documents
4. Collaborate with PrimeVigilance departments on PV processes
5. Participate in audits and inspections
6. Conduct gap analyses of PV systems
7. Support internal initiatives across departments
8. Offer PV consultancy services as per contractual agreements
9. Prepare and deliver advanced PV training internally and for clients
10. Represent the company at international PV conferences
11. Support business development and marketing activities, including creating collateral, writing articles, and webinars
12. Stay updated on PV legislation and assist in interpreting and implementing regulatory requirements
13. Support technological and process improvements within the company
14. Provide leadership, mentorship, and guidance to junior staff or consultants
15. Prepare and present complex PV reports, regulatory documents, and client communications
16. Advise clients on PV regulatory requirements and strategies
Minimum Qualifications
* University degree in a life sciences subject
* Extensive experience in pharmacovigilance, including as an 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 is desirable but not mandatory
* Strong communication, presentation, and leadership skills
* Fluent in English; additional languages are a plus
Additional Information
We prioritize diversity, equity, and inclusion by fostering an equal opportunities workplace and a human-centric environment where all backgrounds, genders, and ages can contribute and grow.
We believe in working together with a human-first approach because our people are our greatest strength, leading to our success in improving lives.
We offer:
* Internal training and career development
* Focus on personal and professional growth
* A friendly and supportive environment
* Opportunities to collaborate globally, with English as the company language
Our core values are central to our operations:
* Quality
* Integrity & Trust
* Drive & Passion
* Agility & Responsiveness
* Belonging
Join us in making a positive impact on patients' lives. We look forward to your application.
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