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.

• Assuming the role of EU/UK QPPV or deputy
• Providing expert advice on all areas of pharmacovigilance
• Authoring and/or reviewing pharmacovigilance procedural documents
• Collaborating closely with Primevigilance departments, providing input into PV processes
• Participating in audits and inspections, as required
• Performing or supporting gap analysis of PV systems
• Supporting different departments in executing internal initiatives
• Providing PV consultancy services in line with applicable contractual agreements
• Preparing and/or performing advanced PV training, internally and for the client
• Representing the company in international pharmacovigilance congresses and conferences
• Supporting BD and marketing activities by creating collaterals, writing articles and preparing webinars
• Keeping abreast of pharmacovigilance legislation and supporting company decisions in interpreting and implementing PV regulatory requirements
• Support internal company projects regarding the technological improvements, as necessary
• Provide leadership, guidance, and mentoring to junior pharmacovigilance staff or consultants.
• Prepare and deliver complex client-facing PV reports, presentations, and regulatory documents.
• Advise clients on PV-related regulatory requirements and strategies for drug safety

Qualifications

• University degree in a life sciences subject
• Solid experience in Pharmacovigilance and previous experience as a EU or UK QPPV in charge of complex PV Systems
• Previous experience in pharmacovigilance inspections
• Experience in business development activities in relation to PV services
• Experience with presenting at international PV events
• Previous experience with Line Management is desirable but not mandatory
• Soft skills: Communication, presentation and leadership skills
• Fluent in English, additional languages are desirable.

Additional Information

• Assuming the role of EU/UK QPPV or deputy
• Providing expert advice on all areas of pharmacovigilance
• Authoring and/or reviewing pharmacovigilance procedural documents
• Collaborating closely with Primevigilance departments, providing input into PV processes
• Participating in audits and inspections, as required
• Performing or supporting gap analysis of PV systems
• Supporting different departments in executing internal initiatives
• Providing PV consultancy services in line with applicable contractual agreements
• Preparing and/or performing advanced PV training, internally and for the client
• Representing the company in international pharmacovigilance congresses and conferences
• Supporting BD and marketing activities by creating collaterals, writing articles and preparing webinars
• Keeping abreast of pharmacovigilance legislation and supporting company decisions in interpreting and implementing PV regulatory requirements
• Support internal company projects regarding the technological improvements, as necessary
• Provide leadership, guidance, and mentoring to junior pharmacovigilance staff or consultants.
• Prepare and deliver complex client-facing PV reports, presentations, and regulatory documents.
• Advise clients on PV-related regulatory requirements and strategies for drug safet