Proclinical is currently looking for two experienced pharmacovigilance scientists with experience in case management.
As a pharmacovigilance scientist you are responsible for case management handling, writing of reports like PSUR's and DSUR's, Risk Management Plans, and will serve as SME for Pharmacovigilance related to company specific products. In addition, you will inform and advice CRO's regarding the safety of company products and you stay in contact with the (local) authorities. The pharmacovigilance department belongs to the Unit Medical & Regulatory Affairs of the company. Within the pharmacovigilance team you are closely working together with a Pharmacovigilance Manager, a Qualified Person Pharmacovigilance and three other pharmacovigilance scientists.
The Pharmacovigilance department is a part of the Medical & Regulatory Affairs Unit of the company specific products. Besides Pharmacovigilance, the unit is also responsible for Medical Affairs, Clinical Research, Registration and Product Development. The unit works closely together with the department Commercial Operations, the Quality Unit and Manufacturing Unit of the company. There is an open, collegial and constructive atmosphere.
Job Responsibilities:
- Ensure timely case management activities for PV related to the collection, processing, and reporting/submission of safety information in accordance with all applicable regulatory requirements and internal procedures.
- Leads and conducts, independently and/or collaboratively on the preparation and authoring of safety reports for assigned products, such as PSURs, DSURs.
- Facilitates signal management process for products and evaluates safety data and signals as part of ongoing pharmacovigilance activities.
- Contribute to the development and maintenance of Pharmacovigilance Site Master File (PSMF), Safety Management plan (SMP), Safety Data Exchange Agreement (SDEA's),
- Participate in the continuous development, implementation and maintenance of the PV system including policies, Standard Operating Procedures (SOPs) to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices
- Other tasks as assigned or required.
Skills and Requirements:
- A Master degree within life science or Medical degree with 4-5 years of experience within the pharmacovigilance and drug safety;
- Experience with case processing, expedited reporting rules, and safety database concepts;
- Experience in writing safety reports and procedures;
- PV experience in relation to Patient Support Programs;
- Good communication and writing skills in English;
- Independent, hands on mentality and collegial;
- Strong organizational skills, including the ability to prioritize independently with minimal supervision.
- Ample development prospects;
- 8.33% year end;
- By fulltime employment, 201 vacation hours;
- Reimbursement of travel expenses;
- Collective agreements with various insurers.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Amber Lakeman on +44 20 3690 593 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
