PV Partnering Alliance Lead
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Hobson Prior are recruiting for a PV Partnering Alliance Lead to join a multinational healthcare company at their offices in Hertfordshire on a 6 month contract.
- Accountable for supporting respective global and business process owners in the development and maintenance of safety agreement templates for all types of contractual arrangements that require safety information acquisition and exchange to ensure regulatory requirements as well as PDS(O) strategy is met.
- Supporting respective global and business process owners in development, deployment and maintenance of fit for purpose safety agreements processes and systems while striving for continuous improvement and compliance.
- Support respective business and global process owners in oversight of implementation of safety agreements, support adoption of changes, and identify performance and compliance issues.
- Support development and deployment of processes, mechanisms to assure delivery of PV Partnering and PDSO strategy.
- Support and advise stakeholders in applying appropriate safety agreements for contractual arrangements to ensure appropriate collection of data from all contractual arrangements that require safety data / information exchange.
- Support the efficient transfer for safety data for product and company acquisitions and facilitate the appropriate documentation of roles and responsibilities in such acquisitions.
- Support the development and maintenance of fit-for-purpose training packages on safety agreement processes, tools and systems.
- Support the day-to-day collaboration and oversight on outsourced safety agreement related activities.
- Support inspection readiness and audit and inspections.
- Good written and verbal communication skills with an international or cross functional perspective, Excellent problem-solving, analytical, impact assessment and strategic and system-thinking skills.
- Good negotiation skills, Ability to collaborate and communicate effectively and efficiently in an international matrix environment.
- Well-developed influencing and negotiating skills, with the ability to influence at all levels of an organisation, without direct authority.
- Conflict management and resolution skills.
- Life Science Degree (e.g. BSc Pharmacology, BSc Biology, BSc Neuroscience, etc.) or qualification in relevant industry areas.
- Good Experience in areas relevant to pharmacovigilance system (3 years), basic experience in safety agreements management, preferred.
- Understanding of the drug development process and regulatory requirements and their impact on safety agreement activities.
- Good knowledge of PV system and GVP/GCP regulations and guidelines.
- Experience in quality management activities and a good understanding of the QMS for the PV System.
- Experience in business partner management; sound understanding of contractual set ups requiring safety agreements is a plus.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.