We are recruiting for a Head of Pharmacovigilance Operations to join an established Pharmaceutical company in Hertfordshire, UK.
You will participate in the management of the on-going functioning of an effective regional Pharmacovigilance network. As part of the role you will provide scientific review and input on documents and signal generation processes. You will also support the Qualified Person and Deputy Qualified Person for Pharmacovigilance.
- Support the Local Safety Officer, the Regional Safety Officer and General Safety Officers in their functions.
- Support the Head of International Pharmacovigilance (Europe) in their functions as Regional – Safety Officer and/or General Safety in the collection, assessment, evaluation, distribution and reporting of safety reports, and product labelling.
- Ensure that assistance is provided to the Pharmacovigilance Systems Manager for the maintenance and upgrade of the global safety database, Business Objects and E2B reporting tool.
- Ensure correct and accurate transposition of source data onto the global AE reporting database.
- Ensure compliant expeditious reporting of Pharmacovigilance Reports to regulatory authorities.
- Said in the scientific review of documents, including but not exclusively, Investigational Brochures, Final Study Reports and Protocols
- Participate as a key member in signal generation process.
- Provide support to the Pharmacovigilance Physicians in the evaluation of Pharmacovigilance Reports
- Ensure that such activities are performed to high standards of quality and timelines that match the best industry standards.
- Compliance to SOP’s, processes, practices and guidelines and aiming towards excellence
- Establish and maintain SOP’s, processes, practices and guidelines.
- Ensure training is provided to all staff in processes and documents appropriate for their role including maintenance of standards including those staff in regional offices.
- Identify new training requirements and establish a training plan for direct line reports
- Manage and appraise the Data-Coordinators and Pharmacovigilance Scientists
- Effectively prioritise workloads and provide daily decisions on safety issues
- Personnel resourcing for the Pharmacovigilance Operations team.
Successful candidates will enjoy the benefits of working with a global Pharmaceutical company, including a COMPETITIVE SALARY, HOLIDAYS, and CAREER PROGRESSION.
- Life science degree or higher qualification
- Science graduate with relevant and proven Pharmacovigilance experience in the Pharmaceutical
- Scientific analyses of complex and disparate data sets, scientific writing and quality assurance requirements will demand that the Head of Pharmacovigilance Operations has taken a lead role in some of these activities and possess either a high level scientific qualification or demonstrable equivalent industrial experience.
- Experience in successfully applying information technology including computer applications and conducting on-line medical searches.
- Prior personnel management experience including development and appraisals.
- Able to form strong cross-functional relationships
- Possess a strong sense of responsibility and have a good track record of working independently and meeting strict deadlines
For more information or to apply for this Head of Pharmacovigilance Operations position, please contact Hendre Moolman at CK Clinical on 01438 870 023 or email email@example.com.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL21579 in all correspondence.