132 days ago on nemensis.force.com

Pharmacovigilance Leader

nemensis ag

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  • Employment type
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 Please refer to JobSuchmaschine in your application

Pharmacovigilance Leader

For our client, a biopharmaceutical company situated in the north-western part of Switzerland, we are looking for a
Pharmacovigilance Leader
This is a temporary assignment for about 6 months
 
Responsibilities:

  • Performs medical review of individual SAEs from clinical trials with the support of the Pharmacovigilance Expert as applicable and is responsible for preparation/submission investigator notifications
  • Prepares clinical expert statements related to signal evaluation (e.g. literature, clinical; non-clinical, epidemiology)
  • Responsible for Case Retrieval Strategy and of ad hoc searches in Argus
  • Responsible for review of study protocols
  • Provides relevant input for internal and external boards and expert panels, as well as internal management teams Communication and cooperation with internal and external responsible persons and service providers
  • Supporting the overall compliance in accordance with the Global Quality System
  • Assists in training of new hires (e.g. PVEs and PVLs) as required
  • Provides support for licensing activities, regulatory authority inspections and for project/product recall activities, as needed
 
Requirements:
  • Degree inmedicineor pharmacy
  • 5-7 years of experience in global drug safety, ideally with big pharma
  • Sound experience with safety regulations and requirements
  • Experience in leading cross-functional and international teams
  • Good writing and communication skills
  • Versed user of MS-Office, Internet and safety databases
  • Fluency in English
 
If you are interested in this innovative position, please send us your complete application documents (CV in German or English, Testimonials, Diplomas, Certificates etc.) by email:
waltraud.bueb@nemensis.com


nemensis ag, the human factor. Your competent recruitment partner specialized in chemistry, biology/biotechnology, pharmaceutics, medical device/engineering and health care.
nemensis ag
Dr. Waltraud Bueb
Kägenstrasse 18
Postfach 557
CH-4153 Reinach
 
Tel: +41 61 205 98 98
Fax: +41 61 205 98 99
www.nemensis.com