Scope of the job
The Pharmacovigilance Manager is responsible for all pharmacovigilance and safety activities for an EORTC study from study development until the archiving of the study. This includes management of all information concerning serious adverse events and serious adverse drug reactions in all studies where the EORTC Pharmacovigilance involvement is described in the protocol.
The Pharmacovigilance Manager is also responsible for protocol review, negotiation/review of contracts, and representation of Pharmacovigilance Department at internal and external meetings. The Pharmacovigilance Manager provides support to the Head of Pharmacovigilance Department.
Main responsibilities / Major Activities
The Pharmacovigilance manager performs tasks for several studies as per Pharmacovigilance latest SOP. This entails:
- Being responsible for day-to-day processing of incoming serious adverse event reports and, where applicable, expedited reporting to regulatory authorities within legal timeframes.
- Ensuring that all Pharmacovigilance activities are conducted in accordance with internal SOP’s, Good Clinical Practice guidelines and regulatory requirements.
- Preparing the study specific SAE-form and guidelines.
- Training site personnel on SAE reporting.
- Attending project based team meetings, phone conferences, and any other safety related meetings.
- Providing safety related support to other EORTC teams during the study (data management, medical, regulatory, clinical operations and project management).
- Preparing the non-medical sections of the Development Safety Update Report and collaborating with medical department for the production of the Safety Update Report.
- Ensuring the reporting of the Development Safety Update Report within the regulatory timelines.
- Writing of SAE chapter of protocol and group specific appendix during the protocol development.
- Full review of protocol and group specific appendix before the start of the study.
- Negotiation and review tasks and responsibilities, contract, PV agreement, cooperation document and other applicable documents in order to have clear procedures in place before the start of the study.
- Attendance to operational meetings with external partners.
- Presentation of the Pharmacovigilance Department to new EORTC staff members and non-EORTC staff members.
- Training of EORTC staff members on Pharmacovigilance
- Training (new) Pharmacovigilance Manager and (new) other Pharmacovigilance staff
- Back-up during absences of other team members (Pharmacovigilance Managers and the Head of Pharmacovigilance Department)
- Performing other non-study specific pharmacovigilance tasks (internal quality checks, process development & improvement…)
- Master’s Degree in Life Sciences (medical/biomedical sciences, pharmaceutical sciences,…)
- 2-5 years SAE processing/clinical safety/pharmacovigilance experience
- Knowledge of clinical/pharmacovigilance regulations
- Knowledge of safety database(s) and/or EudraVigilance submissions
- Good computer skills: MS Windows, Word, Outlook
- Good communication skills: fluent English (spoken and written)
- Ability to work in a structured way
- Ability to work in an independent way
- Ability to speak in public
- Ability to make decisions
- Must be able to prioritize/motivated to meet the reporting deadlines
- Must be a team player, strong diplomatic skills