Patient Safety Lead

Responsible for managing pharmacovigilance (PV) activities in line with Local Operating Companies (LOC) requirements for the DACH region. Supports the development and implementation of processes, systems, and tools for local PV activities, oversees vendor-managed PV tasks. Collaborates with global PV teams, the EU QPPV office, and local stakeholders.

ACCOUNTABILITIES: 

• Management of pharmacovigilance (PV) activities according to Local Operating Companies (LOC) requirements for DACH (Germany, Austria, Switzerland incl. Liechtenstein)
• Support the development and implementation of necessary processes, systems and tools for the handling of local PV activities
• Performs oversight tasks of PV activities outsourced to qualified vendors
• Monitors and oversees local Risk Management Plans (RMPs), risk minimization activities, Market Research (MR) and/or Patient Support Programs (PSPs) relevant for the territory
• Reviews protocols for local studies and defines PV related processes for local study projects
• Works with global PV colleagues and the EU QPPV office as well as with local internal stakeholders
• Takes over responsibilities and tasks of:
  • deputy Graduated Plan Officer (Stellvertretender Stufenplanbeauftragter) acc. to § 63a AMG and §19 AMWHV for Takeda Germany
  • deputy National Appointed Person for Pharmacovigilance acc. to Art. 12 AMBV for Takeda Switzerland

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: 

• Health professional or life sciences degree (Bachelor’s required; advanced degree preferred)
• Minimum of 5 years' advanced experience in pharmacovigilance or related environments
• Meets all applicable local QPPV/PV contact person requirements including education, local language capabilities, training, trustworthiness, and experience
• Advanced experience of working cross-functionally, preferably in R&D companies.
• Understanding of medical/scientific terminology
• Excellent knowledge of PV regulations for the post-marketing global environment and applicable legislation
• Excellent written/oral communication skills in German and English and experience working within virtual teams
• Leadership skills
• Excellent collaborative and organizational skills
• Flexible mindset
• Ability to prioritize under pressure
• High standard of computer literacy
• Execute good documentation practices
• Accuracy and attention to detail

LICENSES/CERTIFICATIONS:

• As required per local QPPV / PV Contact Person requirements, if applicable
  • Residency in the European Union