Drug & Safety Manager

hace 6 meses


Barcelona, España Asphalion A tiempo completo

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**:
Management of the project according Safety Manager. Timely and correct execution of projects according to defined timelines and activities:

- 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 EMA
- Preparation 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**:

- +5 years experience in Pharmacovigilance departments.
- +2 years experience in Team Management & Project Management
- 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 professional, dynamic, ambitious & international working environment.
- An organization with highly professional people to develop with.
- More than 12 nationalities
- A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
- Home Office. Offices in BCN and Madrid, but you can be located anywhere in Spain
- Training and personal development program.
- Flexible working schedule. We enjoy Friday afternoon.
- Social Benefits: English lessons/ Flexible remuneration.
- Permanent contract.


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