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Pharmacovigilance Officer (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Sales, Marketing
Projektbeschreibung
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
- Einsatzort:
-
Projektbeginn:
asap
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Projektdauer:
3 MM++
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb