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Associate director, pv regulatory intelligence

Reading (Berkshire)
IQVIA
Associate director
Posted: 11 September
Offer description

Provide Global Regulatory Intelligence for Clinical and Post approval Pharmacovigilance for LCS and LCS Customers.

Responsibilities

1. Review and scan Regulatory and organization’s websites for Regulatory Intelligence for Clinical and Post approval Pharmacovigilance in line with IQVIA procedures.

2. Proactively monitor ICH, GVP, CIOMs and key agencies for draft legislation, supporting consultation opportunities where available

3. Entry and Quality Review of Global PV Regulatory Intelligence into IQVIA’s Regulatory Information Database

4. Collaborate with IQVIAs EU and Local QPPV network and local offices to collate data.

5. Support Lifecycle Safety with RFI, RFP and BD activities

6. Build and maintain Commercial Model for provision of PV Regulatory Intelligence to LCS Customers

7. Collaborate with LCS departments to understand PV deliverables to ensure corresponding Regulatory Intelligence is available.

8. Assess potential impact of regulatory changes on process or deliverables in collaboration with functional SMEs and/or Process excellence

9. Liaise with Business Development on proposal feasibility

10. Lead bid defense strategy and planning for Regulatory Intelligence offering

11. May act as primary interface for customers

12. Attend internal and customer meetings

13. Lead or support continuous improvement initiatives for processes and infrastructure

14. Lead or support implementation of innovative process, tech or AI for continual improvement.

15. Support Lifecycle Safety Audits and Inspections

16. Cross functional collaboration

17. Provide coverage for Reg intelligence colleagues during absences

18. Mentor, train and/or provide support and guidance to junior team members and peers

Minimum Required Education and Experience

19. Experience: Minimum 5–7 years of relevant Pharmacovigilance experience

20. Education: Bachelor’s degree (preferably in health science or related field)

21. Additional Experience:

5-7 years of relevant Pharmacovigilance experience

At least 3 years of experience with assessing global PV Regulatory Intelligence

5 years in Lifecycle Safety (e.g., Pharmacovigilance, CEVA, Medical Info, Safety Publishing, Risk Management)

Equivalent combinations of education, training, or experience accepted

Practical knowledge of Global PV Regulations

Skills and Abilities

22. In-depth knowledge of Safety service lines, ICH guidelines, GVP modules, and regional requirements

23. Ability to gather and interpret regulatory information

24. Strong business acumen, financial management

25. Proven leadership and motivational skills

26. Strategic planning, project management, and organizational skills

27. Ability to manage multiple delivrables and priorities

28. Effective communication with senior stakeholders

29. Calm, assertive, and diplomatic in challenging interactions

30. Excellent verbal, written, presentation, and negotiation skills

31. Strong customer focus and account management

32. Networking and meeting leadership skills

33. Results-driven in matrix environments

34. Creativity, innovation, and problem-solving

This role is not available for a UK visa sponsorship.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

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