Executive Director, Pharmacovigilance Strategy

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 are proud to have achieved global organic growth year after year, with staff based across Europe, North America, and Asia 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 becoming one of the global leaders in its field. We cover all therapy areas, including medical devices.

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, nurturing an environment from which high-quality client service can be achieved.

Come and join us in this exciting journey to make a positive impact in patients' lives.

The Executive Director, PV Strategy will be a senior expert in pharmacovigilance (PV) with a profound understanding of PV regulations, effective leadership, and communication skills.

This role ensures scientific and medical support for clients throughout the product life cycle, by authoring and reviewing complex PV and regulatory documents and advising on complex PV processes and strategies.

The Executive Director, PV Strategy may act as the 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

Supporting internal company projects regarding technological improvements, as necessary

Providing leadership, guidance, and mentoring to junior pharmacovigilance staff or consultants

Preparing and delivering complex client-facing PV reports, presentations, and regulatory documents

Advising clients on PV-related regulatory requirements and strategies for drug safety

Minimum Requirements :

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 related to PV services

Experience presenting at international PV events

Previous line management experience is desirable but not mandatory

Soft skills : Communication, presentation, and leadership skills

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 in improving the lives of those around us.

We offer :

Training and career development opportunities internally

Strong emphasis on personal and professional growth

Friendly, supportive working environment

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!

Quality

Integrity & Trust

Drive & Passion

Agility & Responsiveness

Belonging

Come and join us in this exciting journey to make a positive impact in patients' lives. We look forward to welcoming your application.

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