Pharmacovigilance Manager - medior allowed (min 2 years exp)
We are actively looking for a PV Manager to work in an international company working on oncology studies.
Why work as a consultant for XPE Pharma & Science?
XPE is a part of The Adecco group, one of the Top 5 companies within the 'Great Place to Work' ranking
- Dynamic colleagues with passion and drive
- The opportunity to develop yourself, your competences and skills within our organization
- An interesting salary with extra-legal benefits. We offer meal vouchers, group- and hospitality insurance.
The Pharmacovigilance Manager is responsible for all pharmacovigilance and safety activities for an intern 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 intern 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.
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 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 inter staff members and extern staff members.
- Training of intern 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, in an independent way
- Ability to speak in public, to make decisions
- Must be able to prioritize/motivated to meet the reporting deadlines
- Must be a team player, strong diplomatic skills.
A very good experience in a nice atmosphere with long term perspective!
An attractive package: salary depending on experience + mealvouchers + insurances + free public transports + extra holidays.
This job is made for you? Don't delay and apply by sending me an email.
You are not ready to apply or have questions? Don't hesitate to contact me and we will discuss in total confidence.
Sybille, 02/801.16.65 or email@example.com