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:
1. Management of pharmacovigilance (PV) activities according to Local Operating Companies (LOC) requirements for DACH (Germany, Austria, Switzerland incl. Liechtenstein)
2. Support the development and implementation of necessary processes, systems and tools for the handling of local PV activities
3. Performs oversight tasks of PV activities outsourced to qualified vendors
4. Monitors and oversees local Risk Management Plans (RMPs), risk minimization activities, Market Research (MR) and/or Patient Support Programs (PSPs) relevant for the territory
5. Reviews protocols for local studies and defines PV related processes for local study projects
6. Works with global PV colleagues and the EU QPPV office as well as with local internal stakeholders
7. Takes 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:
8. Health professional or life sciences degree (Bachelor’s required; advanced degree preferred)
9. Minimum of 5 years' advanced experience in pharmacovigilance or related environments
10. Meets all applicable local QPPV/PV contact person requirements including education, local language capabilities, training, trustworthiness, and experience
11. Advanced experience of working cross-functionally, preferably in R&D companies.
12. Understanding of medical/scientific terminology
13. Excellent knowledge of PV regulations for the post-marketing global environment and applicable legislation
14. Excellent written/oral communication skills in German and English and experience working within virtual teams
15. Leadership skills
16. Excellent collaborative and organizational skills
17. Flexible mindset
18. Ability to prioritize under pressure
19. High standard of computer literacy
20. Execute good documentation practices
21. Accuracy and attention to detail
LICENSES/CERTIFICATIONS:
What we offer you:
A competitive remuneration package with a minimum salary of € 5.598,85 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary is higher and depends on your professional experience and qualifications.
22. Family-friendly company environment; support with parental leave, dad month, Bilingual company kindergarten
23. < depending on the position / department
24. Commuting allowance or parking space (tax applicable)
25. Comprehensive training programs
26. In-house job rotation program
27. In-house Canteen with discounts or meal vouchers
28. Works council (events, festivals, shopping vouchers, etc.)
29. Employee Referral Program
30. Employee Recognition Program
31. Takeda Resource Groups
32. Medical checkups
33. Free vaccination program
34. Fitness Center in I67
35. Employee discounts
36. Employee Stock Purchase Plan
37. Group accident insurance
Locations
AUT - Wien - Technologiestraße 5AUT - Wien - DC Tower
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time