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 clientfacing PV reports presentations and regulatory documents.
- Advise clients on PVrelated regulatory requirements and strategies for drug safety
Qualifications :
University degree in a life sciences subjectSolid experience in Pharmacovigilance and previous experience as a EU or UK QPPV in charge of complex PV SystemsPrevious experience in pharmacovigilance inspectionsExperience in business development activities in relation to PV servicesExperience with presenting at international PV eventsPrevious Line Management experience is desirable but not mandatorySoft skills : Communication presentation and leadership skillsFluent in English additional languages are desirable.Additional Information :
Additional information
We prioritize diversity equity and inclusion by creating an equal opportunities workplace and a humancentric 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 on improving the lives of those around us.
We offer :
Training and career development opportunities internallyStrong emphasis on personal and professional growthFriendly supportive working environmentOpportunity to work with colleagues based all over the world with English as the companylanguageOur 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!
QualityIntegrity & TrustDrive & PassionAgility & ResponsivenessBelongingCollaborative PartnershipsCome and join us in this exciting journey to make a positive impact in patients lives. We look forward to welcoming your application.
Remote Work : Employment Type :
Fulltime
Key Skills
Business Development,Marketing,Pricing,Analysis Skills,Research Experience,Project Management,Research & Development,Strategic Planning,Financial Modeling,Leadership Experience,Management Consulting,Analytics
Department / Functional Area : Business Development
Experience : years
Vacancy : 1