Executive Director, Pharmacovigilance Strategy

Prime Vigilance Ltd; Madrid; Presencial; EUR 60.000 - 100.000; Jornada completa

Descripción de la vacante

Join a forward-thinking company as the Executive Director of Pharmacovigilance Strategy, where you'll lead and innovate in the field of drug safety. This role is pivotal in ensuring compliance with PV regulations, authoring complex documents, and providing expert advice to clients. You'll collaborate with international teams, participate in audits, and represent the company at global conferences. The company values employee well-being and offers a supportive environment for personal and professional growth. If you're passionate about making a positive impact in patients' lives and thrive in a dynamic setting, this opportunity is for you.

Servicios

Training and career development opportunities

Strong emphasis on personal and professional growth

Friendly, supportive working environment

Opportunity to work with global colleagues

Formación

• Solid experience in pharmacovigilance and previous EU/UK QPPV experience.
• Strong communication, leadership, and presentation skills.

Responsabilidades

• Ensure scientific support for clients throughout the product life cycle.
• Author and review complex pharmacovigilance documents.
• Provide leadership and mentoring to junior staff.

Conocimientos

Pharmacovigilance

Leadership

Communication Skills

Presentation Skills

Business Development

Regulatory Knowledge

Fluency in English

Educación

University degree in life sciences

Descripción del empleo

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.