Support the implementation, maintenance and oversight of the local PV system to ensure an efficient and effective PV system that complies with global client
and local legal/regulatory authority PV requirements, safeguarding our License to Operate.
Support the execution of IPS & Affiliate’s Patient Safety (APS) strategies, ensuring high-quality implementation of global and local safety solutions, while demonstrating leadership in ownership, collaboration, and decision-making within assigned responsibilities.

Key Responsibilities

• PV System
• Execution of safety-related activities relevant to the PV (Pharmacovigilance) system through
  partnership with key stakeholders such as Patient Safety Operations and Affiliate PV Net, to
  ensure monitoring of the safety profile of client products and their safety risk management,
  meeting regulatory requirements, and ensuring license to operate. Proactively identify
  opportunities to optimize the PV system.
  Key areas of activities include the following in line with client standard operating procedures
  (where applicable):
• Individual Case Safety Reports (e.g. data collection)
• Signal Detection & Signal Management for Local Products
• Aggregate safety reports (e.g. submission to Health Authority)
• Pharmacovigilance Agreements (e.g. PVA, Safety Data Exchange
• Agreement)
• Risk Management and Safety Communication (e.g., Direct Healthcare
  Professional Communication, Risk Minimization Measures, emerging safety
  issues)
• Studies, Programs and other projects with PV implications (e.g., ICT, NIS,
• PASS, PAES, MAP, PAA, CUP, PTAP, Dicela)
• Safety Labeling and PV Commitments
• (Local) Pharmacovigilance System Master File
• As a contributor, shape country PV regulations and the broader country pharmacovigilance
  ecosystem according to APS grouping, particularly to promote regulatory reliance and
  international harmonization in partnership with (including but not limited to) local pharma
  industry associations, healthcare organizations, patient groups etc. (e.g. simplification of local
  implementation of aRMM together with trade associations and HA).
• Local Safety Risk Management (according to APS grouping)
• Identify, analyze and share safety insights by understanding disease areas (
  patient journey), engaging with key stakeholders, and ensuring timely, proactive integration into
• Affiliate and global strategies.
• Implementation of safety solutions and launch readiness activities: Implement global safety
  solutions locally within the integrated therapeutic strategy, and execute product safety launch
  readiness activities.
• Risk management and safety communication: Support the country-level risk management
  strategy to optimize patient outcomes in collaboration within relevant networks and ensure
  compliant and transparent PV communications (e.g., DHPCs) to healthcare professionals,
  patients, and external partners in collaboration with Medical Affairs and the cross-functional
  team.
  Further responsibilities may include assuming additional roles (e.g. RMP IC, core or extended member
  of the Affiliate Safety Disease Area Communities (ASDACs), Safety Responsible for MAP and DiCELA,
  Disease Area Expert, PV System Expert).

Education/Qualifications

• Qualification and/or Degree in life science or healthcare-related discipline (e.g., PharmD, MSc,
  BSc, Nursing, etc.).

Experience

• Must be a Native Danish Language Speaker

• Immediate Joiners Preferred

• Strong experience in pharmacovigilance, ideally in an affiliate setting

• Understanding of decision-making in the local & global PV ecosystem

Competencies

• Strategic Thinking & Planning
• Understands the basics of strategic planning and its importance.
• Pro-active and strategic mindset; able to think in systems and plan for outcomes.
• Is able to update own and team objectives/actions to reflect changing circumstances
  and to influence strategy for local projects
• Focuses on the fundamentals of execution, including understanding project basics,
  contributing to plans, managing personal tasks, communicating essential information,
  identifying and resolving potential issues, and comprehensively reporting progress.
• Collaboration & Stakeholder Management
• Actively contributes ideas and expertise to local and above country projects.
• Shares experiences and best practices that benefit the network
• Influence to gain support for initiatives from cross-functional teams.
• Understands the structure, key roles and responsibilities of internal stakeholders and
  builds trusting relationships
• Communicates timely and effectively
• Demonstrates an abundance mindset, thinking beyond one's role and team to identify
  wider opportunities and impact

Knowledge & Learning

• Ability to seek information to understand high level drug development
• Basic understanding of drug development, pharmaceutical industry, commercial
  development, and financial standing.
• Understands regulatory requirements and integrates them into daily activities.
• Can clearly speak about process during an audit or inspection
• Seeks feedback on their performance and grows confidence in providing appropriate
  feedback to others

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 https://jobs.iqvia.com

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