Drug & Safety Manager
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.
- Departamento
- Pharmacovigilance
- Locations
- Barcelona
- Remote status
- Fully Remote
Barcelona
Our people are our strength!
Taking care of our people is the basis.
Our employees´ health, safety and well-being are paramount to us.
We are a close organization in an environment of transparent communication.
We offer diversified opportunities and continuous professional growth. You will have the opportunity to integrate in a dynamic team of international scientific prestige and to work in innovative projects.
About Asphalion
ASPHALION is an international Regulatory & Scientific Consulting in Life Sciences with offices in Barcelona, Madrid, Munich and London. Founded in 2000, ASPHALION has grown consistently and currently employs more than 170 team members of over 16 different nationalities.
Drug & Safety Manager
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