Associate Director/Director Pharmacovigilance - Development and Advanced Therapies
Reports to: Managing Director for Pharmacovigilance
Based at: Harlow UK
Diamond Pharma Services is a leading pharmaceutical consultancy dedicated to providing high quality technical support in the areas of Regulatory Affairs, Pharmacovigilance & Quality Assurance.
Thanks to continued expansion of our client base as well as growth in demand from existing clients our pharmacovigilance team is expanding at all levels from PV Officers through to Director-level appointments.
In most cases and where possible we promote and develop staff from within the company. Recruitment for this role is one of the exceptions where we are looking outside Diamond to add senior pharmacovigilance experience to the team.
Our close relationship with our colleagues in Regulatory Affairs and Quality Assurance gives us direct access to senior-level decision makers for clients in Development and/or working on Advanced Therapies such as gene therapy.
Defining and developing a pharmacovigilance strategy and approach for products in their early stages requires a thorough understanding of the legislation and practice of pharmacovigilance as well as close working relationships with our Regulatory Affairs consultants.
We are looking for a dynamic and successful person with over 5 years’ experience of Clinical Trial pharmacovigilance in Europe, able to demonstrate:
- Active interest in pharmaceutical development and/or advanced therapies
- Commitment to their own personal development in best practices in pharmacovigilance
- Definition and application of pharmacovigilance strategies to new or novel situations
This person could be a Team Leader/PV Manager looking for a move to Associate Director, or an Associate Director ready for the move to Director. Excellent references are required.
Overview of the role
- Client Manager for Development & Advanced Therapy clients through their lifecycle: from clinical trials, to licence submission, to marketing, and finally helping clients establish an in-house PV capability.
- Provide PV expertise to our Clinical Trial and Post-Marketing teams from case processing through to cumulative reports.
- Coaching and guidance for our Quality Management System leader.
- Conduct Audits and play a key role in Inspections.
- Train clients on PV and help clients set-up their own in-house PV capability.
- Depending on experience and preference of the candidate, this role may have line management responsibilities.
- Provide PV input and expertise to support our Regulatory Affairs team in business development.