Pharmacovigilance Specialist - Switzerland, Lucerne - Permanent
Clintec is currently looking to hire a Pharmacovigilance (PV) Specialist to join our growing, sponsor office based team in Switzerland. The opportunity is full time (100%) on a permanent contract.
The PV Specialist is responsible for the day-to-day case management activities in Switzerland, including compliance with PV processes/regulations, corporate policies and procedures, as well as the independent processing of adverse events. The position reports to the PV Country Lead.
Responsible for day-to-day adverse experience case management including case intake and follow-up activities, the review of local and health authority submissions of cases
Responsible for aggregate safety report submissions
Responsible for the reconciliation of adverse events reports received from other client operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
Responsible for the filing, storage and archiving of safety-related data
Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection
Assist in the delivery of training to PV staff and customer facing non PV staff
University degree in Life Sciences, Medical Science or another relevant discipline
At least 1 year of pharmaceutical industry experience
Good understanding of Pharmacovigilance regulations in Switzerland as well as pharmacovigilance practices and standards; awareness of Pharmacovigilance systems
Strong project management skills with the ability to prioritize assignments; excellent time management, organizational and planning skills
Proficiency in Good Documentation Practices and awareness of Good Clinical Practice concepts
Compliance mindset/focused, high level of accuracy and quality in work
Familiarity with the use of a safety databases and demonstrated ability to learn new computer interface systems
Strong collaboration skills with the ability to work across boundaries
Proven ability to work independently with minimal supervision
Excellent communication skills in German and English, both verbally and in writing. Additional skills in French would be a plus.
If you have the relevant experience please apply now, if this position isn't the right fit but you are interested in working for Clintec in Switzerland then please send your CV to Adam Davis, Senior Global Resourcing Executive - firstname.lastname@example.org
Clintec is a UK-based, dynamic and privately owned full service Contract Research Organisation with presence in over 40 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over a decade. At Clintec, we pride ourselves on providing high quality, flexible and professional services and solutions to our clients. Clintec has a wealth of experience in managing clinical trials in all major therapeutic areas including oncology, neurology, cardiovascular disease, psychiatry, infectious diseases, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnership with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a market competitive salary and rewards and benefits package.