ProClinical is seeking a Pharmacovigilance Specialist for a global healthcare company that researches, develops, manufactures and markets innovative products with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health. This is a permanent role based in Munich, Germany.
- To perform and/or oversee the collection, documentation, and processing of adverse event (AE) reports from clinical trials and post-marketing sources in accordance with company Standard Operating Procedures (SOPs) and work practices to ensure and maintain regulatory compliance
- To conduct case, follow up with the reporter (including query generation), tracking and exchange with PV centres and CROs
- To monitor third party contractor compliance and performance
- To perform case/safety information reconciliations with business partners
- To conduct literature search and review literature screening search results, identifying case reports and other safety-related findings
- To write or contribute to aggregate reports as required
- To assist with pharmacovigilance processes, supporting preparation of SOPs, as well as deviation and CAPA management in respect to PV
- To assist in product safety review, signal management as required
- To actively implement, track and monitor risk minimization measures
- To support safety management processes
Skills and Requirements:
- Strong communicator and team player with good organisational skills
- Requires a solid understanding of medical and clinical practices, with a strong understanding of medical concepts and terminology
- Must have a working knowledge of global safety reporting regulations and guidelines including the FDA, ICH, & EU Regulations and Requirements for Pharmacovigilance
- Education in healthcare or life sciences (e.g. pharmacy, nursing, physician assistants, nurse practitioners) preferably at a bachelor level (or comparable local degree) or higher.
- Proven track record of several years' relevant work experience in clinical safety or pharmacovigilance
- Preferably familiar with daily clinical and safety database use (e.g. Argus)
- Ability to work independently and within a group environment
- Computer literate, especially in Microsoft Office, experience with safety database
- Excellent written and oral communication skills in English, command of German would be of advantage
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 Jon Stewart on +44 203 7520 318 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.