Need to be fluent in German and English

Recruiter
Cpl Resources
Employment Type
Permanent
Salary
Not disclosed
Cpl Resources logo

Senior Specialist Pharmacovigilance

Main tasks

Provision of pharmaceutical expertise in the entire field of pharmacovigilance

Case Management and Local Literature Screening

Management of safety-relevant information

Case processing (data entry), including translation German/English and quality check of translation

Data entry quality check (without case assessment).

Screening of local scientific literature including creation of search algorithms for local literature screening

Tracking of the internal literature ordering process

Support with creation of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and from the literature; reporting of ICSRs to the competent authorities

Documentation of case processing on a company and a case level

Support in the generation, processing and tracking of follow-up requests

Handling of Customer enquiries or complaints

Assistance in the creation of periodic reports PSURs (Periodic Safety Update Reports)

Assist Manager Pharmacovigilance in managing clinical trials

Quality Systems

Test computerized systems according to validation procedures

Author/review procedural documents such as Working Instructions, SOPs, Working Procedures, templates etc. for pharmacovigilance projects

Organize and perform training of the above-mentioned procedural documents

Perform quality control tasks such as project-specific quality checks

Preparation of and participation in internal and external PV audits/inspections

The successful candidate will have

Medical Documentation specialist or University degree in Life Science

Degree in Life Science or equivalent with proven expertise and experience in GxP and / or

pharmacovigilance (GVP) and related aspects

3-5 years of experience in the field of pharmacovigilance

Excellent knowledge of relevant legislative and non-legislative guidelines on pharmacovigilance

Ability to organize operating procedures and to take over project management duties

Professional verbal and written communication skills with internal and external clients

Fluent in German and English

Excellent written and verbal communication skills

Self-confidence and assertiveness

Confidence to work alone as well as in a team

Strategic, analytical and structured thinking

Ability to assimilate and analyse information rapidly

Flexibility and adaptability

Ability to adjust rapidly to new, unknown, challenging situations

For more information please contact Clodagh DArcy on or email details to