Operating for over 80 years in the pharmaceutical space, this company has grown by consistently staying true to their mission, to bring new innovative medicines that cover current unmet medical, while always putting the patients safety first.
With this as a combined goal, the company has served patients in over 100 countries, has locations in 13 countries in the EU and the US, and grown to 2000 employees.
As a Safety Physician, you will be at the very core of this company’s mission. The successful candidate will be responsible for providing Medical and Surveillance and risk management of products throughout the whole life cycle of multiple products.
Location – Barcelona, Spain
Summary of Key Responsibilities
- Provide overview and Medical Assessments of individual case safety reports
- Participate in the safety surveillance of products, including the review and analysis of adverse report events
- Evaluation of PSUR. Answers to PSURs assessment reports to RAs and PRAC.
- Safety Monitoring and Safety Signal detection activation for the evaluation of the risk benefit ratio – reporting to the committee
- Maintenance of the Reference Safety Information and recommend changes
- Working with local Safety Officers, Partners, CROs in providing Medical information
- Medical Assessments of SUSARs and ASIME
- Preparation and management of the RISK Management Plans and follow through Pharmacovigilance activities, with risk minimisation
- Review DSURs
- Contribute vital safety information for regulatory filing
- Ensure compliance and implementation of internal SOPs
- Specific Background
- Experience in Pharmacovigilance, Clinical Pharmacology, Pharmacoepidemiology, Clinical Development (any phases)
- Knowledge of statistics
- Experience and training on the use of Safety Databases
- Demonstrable knowledge of the MedDRA dictionary
- Midpoint of €84,000 total compensation (base and bonus) (flexible based on experience)
- Very strong health-care package (private medical, Life insurance, in-house doctor)
- Flexible working for home base/office based
Interested in finding out more? Then please send a CV or just drop me a message directly!