Description
An excellent opportunity has arisen for a Pharmacovigilance Manager to join an expanding team based in West London. The ideal candidate will have a strong background in processing and reviewing individual case safety reports, author and review aggregate reports and maintenance of drug dictionary, ideally within a consulting or CRO environment.
Responsibilities:
*Act as a member of the project management team and oversee successful initiation, execution and completion of PV programs for global clients.
*Responsible for process implementation and ensuring process compliance.
*Responsible for work allocation, compilation and reporting of the program reports on timely basis.
*Takes a role on contract discussions and negotiations for any assigned programs and brings in the relevant internal parties to ensure a satisfactory conclusion regarding new or extension of contracts.
*May proactively identify business development opportunities and internal business development efforts.
*Leads meetings with client on a regular basis to understand the client's requirement for a particular program and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints.
*Responsible for the performance management of the program team on an ongoing basis. This may include regular interaction with team members, identifying the areas of improvement and implementing a subsequent training or mentoring plan to ensure all the team members meet or exceed targets with highest level of employee satisfaction.
Skills & Experience
*Significant relevant PV experience either in a pharmaceutical company or with a CRO.
*Literature management experience (managing a literature program or having played a key role in a literature based project).
*Familiarity with literature legislation and implementation.
*Good understanding of clinical development processes including principles of clinical study operations, and ICH-GCP guidelines.
*Experience in managing teams in PV domain.
*A minimum of a graduate degree in life sciences.
*Working knowledge of basic computer applications, e.g. MS Word, PowerPoint.
For further details about this role, or other opportunities within PV, please call Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk