Full-Time Executive Director, PV Strategy
Ergomed is hiring a remote Full-Time Executive Director, PV Strategy. The career level for this job opening is Manager and is accepting Guildford, United Kingdom based applicants remotely. Read complete job description before applying.
Ergomed
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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.
Responsibilities:
- Authoring and/or reviewing pharmacovigilance procedural documents
- Collaborating with Primevigilance departments, providing input into PV processes
- Participating in audits and inspections
- Performing or supporting gap analysis of PV systems
- Supporting different departments in executing internal initiatives
- Providing PV consultancy services
- Preparing and/or performing advanced PV training
- Representing the company in international pharmacovigilance congresses and conferences
- Supporting BD and marketing activities
- Keeping abreast of pharmacovigilance legislation
- Supporting company decisions in interpreting and implementing PV regulatory requirements
- Support internal company projects regarding technological improvements
- Providing leadership, guidance, and mentoring to junior staff
- Preparing and delivering client-facing PV reports, presentations, and regulatory documents
- Advising clients on PV-related regulatory requirements and strategies
- Line management responsibilities: Line management of direct reports, coaching, and mentoring
- Regular 1:1 meetings with direct reports
- Periodic appraisal of performance and goal setting
- Managing team performance
- Supervising, training, and developing colleagues
- Providing training to other employees and clients
Qualifications:
- University degree in a life sciences subject
- Solid experience in Pharmacovigilance
- Previous experience as a EU or UK QPPV
- 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
Skills:
- Communication
- Presentation
- Leadership
- Fluent English