Company Description
We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance.
PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device.
We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved.
Come and join us in this exciting journey to make a positive impact in patient’s lives.
Job Description
The Executive Director, PV Strategy will be a senior expert in pharmacovigilance (PV) with profound understanding of PV regulations, effective leadership and communication skills.
This role ensures scientific and medical support for the clients throughout the product life cycle, by authoring and reviewing of complex PV and regulatory documents and ability to advise on complex PV processes and strategies.
The Executive Director, PV Strategy may act as European Union/United Kingdom Qualified Person Responsible for Pharmacovigilance and provide expert advice on all areas of pharmacovigilance.
1. Assuming the role of EU/UK QPPV or deputy
2. Providing expert advice on all areas of pharmacovigilance
3. Authoring and/or reviewing pharmacovigilance procedural documents
4. Collaborating closely with Primevigilance departments, providing input into PV processes
5. Participating in audits and inspections, as required
6. Performing or supporting gap analysis of PV systems
7. Supporting different departments in executing internal initiatives
8. Providing PV consultancy services in line with applicable contractual agreements
9. Preparing and/or performing advanced PV training, internally and for the client
10. Representing the company in international pharmacovigilance congresses and conferences
11. Supporting BD and marketing activities by creating collaterals, writing articles and preparing webinars
12. Keeping abreast of pharmacovigilance legislation and supporting company decisions in interpreting and implementing PV regulatory requirements
13. Support internal company projects regarding the technological improvements, as necessary
14. Provide leadership, guidance, and mentoring to junior pharmacovigilance staff or consultants.
15. Prepare and deliver complex client-facing PV reports, presentations, and regulatory documents.
16. Advise clients on PV-related regulatory requirements and strategies for drug safety
Qualifications
1. University degree in a life sciences subject
2. Solid experience in Pharmacovigilance and previous experience as a EU or UK QPPV in charge of complex PV Systems
3. Previous experience in pharmacovigilance inspections
4. Experience in business development activities in relation to PV services
5. Experience with presenting at international PV events
6. Previous experience with Line Management is desirable but not mandatory
7. Soft skills: Communication, presentation and leadership skills
8. Fluent in English, additional languages are desirable.
Additional Information
We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.
To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us.
We offer:
1. Training and career development opportunities internally
2. Strong emphasis on personal and professional growth
3. Friendly, supportive working environment
4. Opportunity to work with colleagues based all over the world, with English as the company language
Our core values are key to how we operate, and if you feel they resonate with you then PrimeVigilance could be a great company to join!
1. Quality
2. Integrity & Trust
3. Drive & Passion
4. Agility & Responsiveness
5. Belonging
6. Collaborative Partnerships
Come and join us in this exciting journey to make a positive impact in patient’s lives. We look forward to welcoming your application.
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