Senior Drug & Safety Officer

Purpouse of the role: Are you interested in help in detecting, preventing problems and evaluating adverse drug reactions? Do you want to join our pharmacovigilance unit? This is for you!
Main responsabilities: Weekly global or local literature review.
Handling of ICSRs and follow-up.
Translation of information into English.
Contact with the Spanish Regulatory Authorities.
Assistance Qualified local contact in Spain for pharmacovigilance.
Keep Client informed about local pharmacovigilance legislation.
Informing and updating the company about all changes regarding the requirements of the local Regulatory Authorities.
Maintenance PSMF and Asphalion Pharmacovigilance System (SOPs).
xEVMPD submissions to EMAPreparation of PSURs, RMP, PSMF, CCSI.
Medical Advisor.
Preparation of draft Pharmacovigilance contracts.
Reporting of cases to the European authorities through EudraVigilance.
Case processing of non-serious cases through data base.
Requirements: +3 years experience in Pharmacovigilance departments. Fluent in English & Spanish. Previous experience working in an international environment. Academic Degree in Life Science and Pharmacovigilance. Advanced IT level – (MS Office). Proactive, good communication, accurate, detail orientated. We offer you: A highly, dynamic & international working environment with employees from more than 15 nationalities.
A professional, inclusive and high-performance work environment to develop your skills and grow your career.
A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
Training and personal development program.
Flexible working schedule - Compacted workday on Friday.
Social Benefits: English lessons, wellbeing programme, flexible remuneration.
Home Office - Hybrid or Remote Model

Permanent contract.

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