Nymphenburger Str.120, 80636 München+49 (0)89 80913072-0info@triga-consulting.de
Contact info
Nymphenburger Str.120, 80636 München+49 (0)89 80913072-0info@triga-consulting.de

Düsseldorf: Associate Director Drug Safety/Stufenplanbeauftragter (gn) | Pharma | Festanstellung

An exciting opportunity has arisen to join an international pharmaceutical company with a successful product portfolio and promising pipeline.
The focus of this company is on rare diseases and orphan drugs. For the affiliate in Düsseldorf we are searching for a:

Associate Director Drug Safety/Stufenplanbeauftragter (m/w/d)

We offer:

  • Extensive training and a very friendly team
  • Above average salary and benefits package
  • Opportunities for personal and professional growth
  • Great flexibility incl. >40% homeoffice, also after Corona
  • Excellent working conditions

Main function(s): 

  • Undertake European Drug Safety and support Medical Information activities including the local duties of the responsible person (Stufenplanbeauftragter) for Germany.
  • Graduated Plan Officer (Stufenplanbeauftragter – § 63a AMG) to ensure that duties related to Pharmacovigilance are carried out in compliance with the applicable legislation.
  •  Act as Deputy Responsible Person according to Medicinal Products Law (Stellvertretender Großhandelsbeauftragter – § 52a AMG).
  • Act as Information Officer (Informationsbeauftragter – § 74a AMG).
  • Manage local expense / budget expenditure.
  • Note: In addition to these functions employees are required to carry out such other duties as may reasonably be required.

Main duties / responsibilities:

  • Drug Safety activities
  • Implementing and maintaining the local drug safety system
  • Keep up to date with current European Pharmaceutical regulations / guidelines in particular those pertinent to the DACH region and ensure that all requirements are met.
  • Ensure that Global and local SOPs and Work Instructions are followed and that local documents are kept up-to-date.
  • Produce new safety-related SOPs / WIs as and when needed.
  • Provide PV/Safety training to company staff and potentially business partners
  • Collecting and internal reporting of safety data from authorities, healthcare professionals, literature, patients or the public
  • Supporting the maintenance of the local language literature collection and periodic review
  • Supporting the EU-QPPV (Qualified Person Pharmacovigilance) as and when required
  • Participate in PV activities for Global development project as and when required
  • Deputise for the Deputy General Manager, PQA / Responsible Person:
  • Participate in relevant Drug Safety and PQA, QSM meetings

Qualifications / education required:

  • University degree in either human medicine, pharmacy, human biology, veterinary medicine, biology or chemistry
  • Eligible to be named as a Stufenplanbeauftragter according to § 63a AMG (Graduated Plan Officer for PV)
  • Eligible to support the Information Officer (Informationsbauftragter) according to §74a AMG for MTPD
  • Eligible to act as Deputy Responsible Person

Experience:

  • At least 8 years professional experience in pharmaceutical industry, with at least 5 years in drug safety.
  • Fluent English and German in speaking and writing
  • Scientific knowledge in the products of the company and the respective indication areas
  • Appropriate competence and experience GVP
  • Knowledge of the respective laws and regulations relating to PV, code of practice and GDP for MA holders
  • Familiar with global safety databases
  • Working knowledge of ARGUS is desirable but not essential.

Do you want to know more about this position? Then please send your complete application to:
Mariana Chaumont or Silvio Di Meglio
Triga Consulting GmbH & Co. KG
Tel.: 0049-(0)89-80913072-1
dimeglio@triga-consulting.de
www.triga-consulting.de

 

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