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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

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.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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