Senior Drug & Safety Officer

We Are Hiring_Senior PV

Senior Drug & Safety Officer

Our team in Barcelona is growing!

Our team’s mission is our passion: to work together with our clients to generate ideas and implement solutions that contribute to better health in all our lives.

Are you interested in helping to detect, prevent and evaluate adverse drug reactions? Would you like to join our pharmacovigilance department? This is for you!

Main responsibilities:

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

Key-Activities:

  1. Overall management of Pharmacovigilance Activities (PSURs, RMP, PSMF, literature review, Handling of ICSRs etc)
  2. Preparation of new CCSIs or update of CCSI: Asphalion technicians shall draw up the draft CCSI and related documents.
  3. Management of the project
  4. xEVMPD submissions to EMA
  5. Timely and correct execution of projects assigned
  6. Quality check of activities
  7. Responsible person for specific client as assigned to Pharmacovigilance group
  8. Communication with clients on ongoing and possible future project
  9. Internal training of Asphalion employees in Pharmacovigilance topics
  10. Establishing processes and working instructions

Requirements:

  • +4 years experience experience in Regulatory Affairs and Pharmacovigilance departments.
  • +2 years experience in Project Management.
  • Fluent in English & Spanish
  • Advanced IT level – (MS Office)
  • Academic Degree in Life Science and Pharmacovigilance.
  • Proactive, good communication, accurate, detail orientated.

We offer you:

  • A highly professional, dynamic, ambitious & international working environment with flat hierarchies and short decision paths.
  • More than 12 nationalities!
  • A great company culture built around Passion, Flexibility, Commitment, Quality & Companionship.
  • An organization with highly professional people to develop with.
  • Flexible working schedule and Social Benefits.
  • Home Office
  • Permanent Contract
  • Career Path Development
  • Annual training Plan
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