Patient Safety Officer Denmark (12-month fixed-term contract)

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 & Affiliates 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 ones 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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements misrepresentations or material omissions during the recruitment process will result in immediate disqualification of your application or termination of employment if discovered later in accordance with applicable law. We appreciate your honesty and professionalism.