Shortlist Deputy Head Of Pharmacovigilance Deputy Head Of Pharmacovigilance

Deputy Head of Pharmacovigilance

Pharmaceutical/Biotechnology

Switzerland

£80,000 - £100,000

Burns Carlton are specialists within Healthcare/Pharmaceuticals/Biotechnology recruitment. For further information on Senior Healthcare Pharmaceutical Jobs or Healthcare Pharmaceutical Executive Recruitment please contact Burns Carlton's specialist team on 0203 008 7500 or via email at lon2@burnscarlton.com

Our client is a global biotech company that focuses on the development, production and marketing of vaccines and antibodies to prevent and combat infectious and other diseases.
In order to strengthen the team they are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to the organisation. Within organisation talented, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points.

Main activities:

• Handling, assessing, coding, evaluation and validation of individual case safety reports, incl Authority Reporting


• Support in reviewing the safety-related sections of clinical trial documents


• Support in preparation of Periodic Safety Update Reports and other reports on benefit/risk statements


• Writing, updating and maintaining SOPs and supporting documents relating to Crucell's global Pharmacovigilance processes


• Pharmacovigilance training of company personal


• Interaction with the local Pharmacovigilance Respopnsibles in Crucell's Group Companies


• Resolving safety issues pertaining to medical queries in clinical trials


• Trading safety-related medical questions


• Support in preparing, maintaining and updating safety data exchange agreements with external partners


• Maintenance of the pharmacovigilance-literature database

Key responsibilities:

• Assurance of the quality of the global pharmacovigilance processes


• Medical review and validation of individual case safety reports and safety reports from clinical trials


• Writing of case narratives and pharmacovigilance comments of the individual case safety reports and safety reports from clinical trials


• Writing of Periodic Safety Update Reports and other benefit/risk evaluations and statements


• Safety-related medical questions

Requirements:

• University degree preferrably in Medicine, Pharmaceutical Sciences or Pharmacology


• Over 5 years of significant experience in pharmacovigilance, preferrably on a global level


• Profound knowledge and understanding of immunology as well as of clinical development


• Profound understanding of the regulatory framework, knowledge of pharmacovigilance regulations and methodology


• Profound knowledge and understanding of process-driven activities


• Experience in managing compliance with internal SOPs, Working Procedures, and extrenal regulations


• Good command of English and preferrably German (any additional language would be a plus)


• Scientific rigor in analysing and interpreting data


• Ability to interact with health care professionals, investigators and patients


• Ability to work in a small team in a global environment, to work goal-oriented and to multi-task


• Strong interpersonal and leadership skills

If you are interested in this position, please apply below.

Link directly to this vacancy: http://www.burnscarlton.com/21769