Full-Time Executive Director, Pharmacovigilance Strategy

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 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.

Responsibilities include:

• 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
• 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 Line Management experience is desirable but not mandatory

Soft skills:

• Communication, presentation and leadership skills
• Fluent in English, additional languages are desirable

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