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Director, Global Head of PV Agreements
- Drug Safety / Product Safety
- Permanent
This vacancy has now expired. Please see similar roles below...
Proclinical is seeking a Director for Global Head of PV Agreements for a multinational, speciality pharmaceutical and medical device company anchored by a collection of world-class franchises and 22,000 employees worldwide. This position will assume responsibility for the preparation and maintenance and tracking of Safety Data Exchange Agreements (SDEAs), it is a permanent position to be based in the UK.
Job Responsibilities:
- Manages the global SDEA Team
- Manages all SDEA functions in all regions globally
- Communicates the pharmacovigilance impact in business agreements with Business Development and other Local parties (i.e., GM) responsible for the creation of business agreements
- Trains/educates Business Development and other Local parties (i.e., GM) responsible for the creation of business agreements regarding notifications to SDEA Team, involvement of GPRM in business agreements, and impact to GPRM
- Provides training and guidance to SDEA team
- Provide process improvements to SDEA team and relevant GPRM team members and/or external Departments with regard to the SDEA function
- Manages activities related to the SDEA GSOP, GREF's, GTEM's, etc.
- Acts as contact point for business partners, other departments, third party provider(s) and authorities regarding SDEAs
- Maintain pharmacovigilance expertise, understanding of international safety regulations and guidelines. Develops, communicates, and implement best practices, SOPs, templates, work instructions, etc. as called for or specified in assigned tasks and projects.
- Direct reporting to Global Head of Pharmacovigilance Operations
- Dotted line reporting to EU QPPV
- Responsible for coordination of SDEAs in all regions globally
- Responsible for Direct Reports in various regions globally
Skills and Requirements:
- Pharmacist of Health Science Degree preferred.
- At least 5 years of experience in Pharmacovigilance required.
- Experience in SDEAs preparation required.
- Strong organizational skills, detail-oriented, ability to adapt to a fast-paced and changing environment
- Proven written and oral communication skills in English
- Ability to work under pressure to meet tight deadlines
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on +44 207 4400 636 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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