Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.

Pharmacovigilance Officer (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Sales, Marketing

Projektbeschreibung

REFERENZNUMMER:

301867/1

IHRE AUFGABEN:

-Supervise local drug safety
-Creating and implementing SOPs in accordance with German legislation and regulations relating to the pharmaceutical industry and global SOPs
-Ensure compliance with corporate Drug Safety policy and maintain close working contact with Global Drug Safety
-Manage the local Drug Safety database (Excel, AE Tracker)
-Registration and follow-up of reported AEs in Germany
-Medical review of adverse events
-Follow-up of safety signals of PMS studies in collaboration with Global Drug Safety
-Oversee and follow-up of discontinuations in Germany
-Reporting of AEs to Global Drug Safety according to legal requirements and corporate SOPs
-Review literature information for adverse event information
-Compiling and updating material for employee training in pharmacovigilance
-Conducting trainings of sales team in cooperation with the Medical Director and General Manager

IHRE QUALIFIKATIONEN:

-B. Sc. in Life Sciences or higher
-Experience in the pharmaceutical industry, preferably with international experience in a Drug Safety and/or regulatory function
-Clinical trial experience within the pharmaceutical environment
-Strong working knowledge of the German legislation and regulations relating to the pharmaceutical industry, as well as ICH guidelines is required
-Experience with collection and reporting of Serious Adverse Events (SAEs) associated with investigational drugs (i.e. SAEs from Clinical Trials) as well as AEs associated with post-marketing products
-Strong written and verbal communication skills in English
-Computer literacy regarding MS Office programs
-Excellent interpersonal skills, ability to work independently as well as in a team
-Ability to manage complex communication issues and to establish fruitful working relationships to partners internally and externally
-Attention to detail, excellent prioritisation skills as well as strong analytical and diagnostic skills regarding problem solving

WEITERE QUALIFIKATIONEN:

Drug safety manager

Projektdetails

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland