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)
- 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
- 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
- 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
TRIGA – Wir vermitteln nicht nur Personal, sondern Menschen. Engagiert, erfahren und erfolgreich.