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Associate Director, Pv Regulatory Intelligence

3 years
Not Disclosed
10 Sept. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Global Regulatory Intelligence – Clinical & Post-Approval Pharmacovigilance

(LCS & LCS Customers Support)


About the Role

This role provides global regulatory intelligence support for clinical and post-approval pharmacovigilance (PV), both internally for Lifecycle Safety (LCS) and externally for LCS customers. The position requires strong expertise in global PV regulations, proactive monitoring of regulatory developments, and close collaboration with cross-functional teams to ensure compliance and business growth.


Key Responsibilities

Regulatory Intelligence & Monitoring

  • Review and scan regulatory and organizational websites in line with IQVIA procedures.

  • Proactively monitor ICH, GVP, CIOMs, and key regulatory agencies for new and draft legislation.

  • Identify and support consultation opportunities where available.

  • Assess the potential impact of regulatory changes on processes and deliverables in collaboration with SMEs and process excellence teams.

Regulatory Database & Documentation

  • Perform entry and quality review of global PV regulatory intelligence in IQVIA’s Regulatory Information Database.

  • Collaborate with EU/local QPPVs and local offices to collate and validate regulatory data.

Collaboration & Customer Support

  • Support LCS teams with RFI, RFP, and business development activities.

  • Build and maintain a commercial model for PV regulatory intelligence offerings.

  • Collaborate with LCS departments to align regulatory intelligence with PV deliverables.

  • Act as the primary interface for customers when required.

  • Liaise with Business Development on proposal feasibility and lead bid defense strategies.

Continuous Improvement & Innovation

  • Lead or support continuous improvement initiatives across processes and infrastructure.

  • Drive implementation of innovative processes, technologies, and AI solutions for regulatory intelligence.

  • Support LCS audits and inspections as needed.

Leadership & Training

  • Provide mentorship, training, and guidance to junior colleagues and peers.

  • Offer coverage and support for regulatory intelligence colleagues during absences.

  • Demonstrate strong leadership, project management, and organizational skills in a matrix environment.


Qualifications & Experience

  • Education: Bachelor’s degree in health sciences or related field (or equivalent combination of education, training, and experience).

  • Experience:

    • 5–7 years of relevant pharmacovigilance experience.

    • At least 3 years of hands-on experience in assessing global PV regulatory intelligence.

    • 5 years in Lifecycle Safety (e.g., PV, CEVA, Medical Information, Safety Publishing, Risk Management).

  • Knowledge: Practical understanding of global PV regulations, ICH guidelines, GVP modules, and regional requirements.


Skills & Competencies

  • Strong ability to gather, analyze, and interpret regulatory information.

  • In-depth knowledge of PV service lines and global regulatory frameworks.

  • Business acumen and financial management capability.

  • Proven leadership and motivational skills.

  • Strategic planning, project management, and multitasking ability.

  • Excellent communication (verbal, written, presentation, negotiation).

  • Strong customer focus and account management experience.

  • Effective in stakeholder engagement, networking, and leading meetings.

  • Calm, assertive, and diplomatic in challenging situations.

  • Results-driven with a creative and problem-solving mindset.


Additional Information

  • This role is not available for UK visa sponsorship.

  • IQVIA is a global leader in clinical research services, healthcare intelligence, and commercial insights, committed to accelerating the development and commercialization of innovative medical treatments to improve patient outcomes.

  • Learn more: https://jobs.iqvia.com