Patient Safety Lead

Takeda; Wien; Vor Ort; EUR 60 000 - 90 000; Vollzeit

Zusammenfassung

A leading pharmaceutical company is seeking a Pharmacovigilance Manager to oversee PV activities in accordance with local regulatory requirements for the DACH region. This role involves collaborating with global teams, managing vendor tasks, and ensuring adherence to PV regulations while providing essential processes and systems for local activities.

Qualifikationen

• Minimum of 5 years' experience in pharmacovigilance or related fields.
• Proficiency in German and English.
• Understanding of medical/scientific terminology and PV regulations.

Aufgaben

• Management of pharmacovigilance activities as per LOC requirements.
• Collaboration with global PV colleagues and local stakeholders.
• Oversight of vendor-managed PV activities and local RMPs.

Kenntnisse

Collaboration

Organizational skills

Attention to detail

Ability to prioritize under pressure

High computer literacy

Ausbildung

Health professional or life sciences degree

Jobbeschreibung

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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 including Liechtenstein)
• Support the development and implementation of necessary processes, systems, and tools for handling local PV activities
• Oversees PV activities outsourced to qualified vendors
• Monitors and oversees local Risk Management Plans (RMPs), risk minimization activities, Market Research (MR), and Patient Support Programs (PSPs) relevant for the territory
• Reviews protocols for local studies and defines PV-related processes for local study projects
• Collaborates with global PV colleagues, the EU QPPV office, and local internal stakeholders
• Assumes responsibilities of deputy Graduated Plan Officer according to § 63a AMG and §19 AMWHV for Takeda Germany, and deputy National Appointed Person for Pharmacovigilance according 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' experience in pharmacovigilance or related fields
• Meets all local QPPV/PV contact person requirements, including education, language skills, training, trustworthiness, and experience
• Experience working cross-functionally, preferably in R&D companies
• Understanding of medical/scientific terminology
• Excellent knowledge of PV regulations for global post-marketing environments and relevant legislation
• Proficiency in German and English, with experience working in virtual teams
• Strong collaboration and organizational skills
• Ability to prioritize under pressure
• High computer literacy
• Adherence to good documentation practices
• Attention to detail and accuracy

LICENSES/CERTIFICATIONS:

Locations:

• AUT - Wien - Technologiestraße 5
• AUT - Wien - DC Tower

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