Patient Safety Lead

Patient Safety Lead

Erstellt mit künstlicher Intelligenz

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Job Description

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

LocationsAUT - Wien - Technologiestraße 5

Worker TypeEmployee

Worker Sub-TypeRegular

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