RA/PV Manager (RE-33511804) München, Deutschland

aktuell suchen wir für einen unserer großen Pharmakunden im Münchner Großraum einen Manager in der Schnittstelle RA und PV.
Anbei finden Sie eine detaillierte Arbeitsbeschreibung.
Rahmenbedingungen: Start: 01.09.2020
Dauer: 1 Jahr
Auslastung: 32 Stunden/ Pro Woche
Standort: Münchner Großraum
Homeoffice: auf Anfrage

Jobbeschreibung:
1. Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all products from non-interventional studies, Patient Oriented Programs, Spontaneous Reports. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.

2. Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.
3. Interact and exchange relevant safety information with local HA, Patient Safety associates, other functional groups and third party contractor, if applicable.

4. Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.

5. Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.

6. Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.

7. Manage and maintain efficient Patient Safety filing and archive system.
Falls dies ein spannendes Projekt für Sie ist, freue ich mich sehr auf Ihre Rückmeldung. Wenn Ihnen ein geeigneter Kollege einfällt, können Sie sehr gerne diese Mail weiterleiten oder den Kandidaten mir empfehlen.

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