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Job Description

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 activitiesPerforms oversight tasks of PV activities outsourced to qualified vendorsMonitors and oversees local Risk Management Plans (RMPs), risk minimization activities, Market Research (MR) and/or Patient Support Programs (PSPs) relevant for the territoryReviews protocols for local studies and defines PV related processes for local study projectsWorks with global PV colleagues and the EU QPPV office as well as with local internal stakeholdersTakes over responsibilities and tasks of:deputy Graduated Plan Officer (Stellvertretender Stufenplanbeauftragter) acc. to § 63a AMG and §19 AMWHV for Takeda Germanydeputy 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 environmentsMeets all applicable local QPPV/PV contact person requirements including education, local language capabilities, training, trustworthiness, and experienceAdvanced experience of working cross-functionally, preferably in R&D companies.Understanding of medical/scientific terminologyExcellent knowledge of PV regulations for the post-marketing global environment and applicable legislationExcellent written/oral communication skills in German and English and experience working within virtual teamsLeadership skillsExcellent collaborative and organizational skillsFlexible mindsetAbility to prioritize under pressureHigh standard of computer literacyExecute good documentation practicesAccuracy 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

Time TypeFull time