Hendre Moolman at CK Clinical is recruiting for a Senior Pharmacovigilance Officer to join a global pharmaceutical company in a contract role in Berkshire.
As a Senior Pharmacovigilance Officer the main purpose of your role will be to contribute to the monitoring of the safety of the Group’s products, both during development and after marketing authorisation approval, in order to meet international regulatory requirements, the Company’s development objectives and clinical excellence.
Further responsibilities of this Senior Pharmacovigilance Officer position will include:
- Assist in the maintenance of systems to ensure accurate monitoring of the safety of the Group’s products both during development and after marketing authorisation approval.
- Contribute to the maintenance and quality of the Group’s central safety database
- Make recommendations concerning individual case submissions to regulatory authorities and licensing partners
- Communicate with healthcare professionals to obtain supplementary information on serious adverse events and serious adverse reactions to the Group’s products
- Contribute to the preparation of accurate, high quality pharmacovigilance reports within agreed regulatory timelines to assist in meeting the Company’s development targets and excellence
- Proactively facilitate the safe progress of clinical trials for products in development by liaising with the clinical study teams and providing regular reports and advice concerning all matters relating to safety to the clinical team
- Participate in devising and approving the safety workflow sequence for the reporting and follow-up of serious adverse events during clinical trials
- Contribute to the efficient and timely production of clinical trial documentation
- Provide an overview of pharmacovigilance definitions and procedures to study investigators and site monitors at study set-up, and whenever necessary during the running of the trial, to ensure that serious adverse events are reported to the Company in a timely and complete manner
- Ensure that serious adverse event data within the central safety database and the clinical study database are reconciled in an accurate and timely manner for all clinical trials
- Liaise with CRO staff to ensure that serious adverse events are reported to the Company in a timely manner and understand their responsibilities for processing safety data as described in the RFP and Contract
- Preparation and/or review the pharmacovigilance sections of draft document templates and standards e.g. Protocol template and Request for Proposal template
- Contribute to the development of training courses for external and internal staff.
- Maintain awareness of changes to regulatory guidance documents, requirements and state-of-the-art pharmacovigilance processes and make recommendations.
Qualifications and skills:
As a Senior Pharmacovigilance Officer you will have the following qualifications, skills and experience:
- Life Science degree
- Ability to produce high quality, accurate work to meet deadlines
- Well developed time management, communication, presentation, analytical and interpersonal skills
- Responsible, flexible and reliable with a pro-active approach and able to work to deadlines
- Ability to plan and prioritise workload
As a Senior Pharmacovigilance Officer you will be joining a global pharmaceutical company at their site based in berkshire with the following aspects:
- You will be working with a global company
with a strong pipeline in variety of therapy areas
- You will have a competitive rate
- Initial 6-month contract
For more information or to apply for this Senior Pharmacovigilance Officer position please contact Hendre Moolman on +44 (0)1438 842 970 or email firstname.lastname@example.org.
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