PV Compliance Officer (H/F)

The PV Compliance Officer is a part of PV Systems and Tools unit, belonging to Case Management and Pharmacovigilance Systems Unit within Global Safety Department. This PV Systems and Tools unit is mainly responsible for configuration and maintenance of the PV systems, especially the Global Safety Database (Argus Safety) and the Business Intelligence and reporting solution. The team is also an important contributor of IT related projects and to support users in their daily activities.

She/ he is responsible for:

• Contributing to maintain/improve quality performance and compliance of operational PV activities
• Monitoring of the KPIs and compliance metrics in collaboration with the concerned units
• Contributing to development of relevant KPIs and metrics in collaboration with technical team
• Contributing to audit and inspection readiness, including preparation and participation in interviews with third parties and health authorities

Partnering with business teams to support continuous improvement initiatives and ensure PV processes remain efficient, compliant and inspection-ready

Activities & Responsibilities

She/ he is responsible for:

• Investigating and documenting instances of late submissions (ICSR, Aggregate Reports, ESI and any other PV submissions/commitments) to regulatory bodies, monitoring the timely exchange of ICSRs with Business Partners.
• Generation, quality review, and distribution of compliance and quality metrics and trending analyses.
• Coordinating compliance, quality, and process improvement initiatives providing input into corrective/preventative actions (CAPAs) and measuring their effectiveness as appropriate.
• Monitoring and escalation of compliance issues related to global PV obligations to senior management.
• Contributing to the Identification of potential quality failures and initiate corrective measures as needed.
• Contributing to monitoring vendor quality performance in collaboration with the operational teams, investigate and document scores below thresholds.
• Partnering with key stakeholders to ensure robust corrective/preventative actions and effectiveness checks are implemented
• Collaborating with key stakeholders to ensure metrics are fit for oversight purposes and meet regulatory expectations
• Developing, reviewing, implementing, and/or validating metrics presentations, visualizations, and reports ensuring clarity and usability

General responsibilities

She/ he is responsible for:

• Creating and maintaining quality documents related to her/his scope of activities ensuring alignment with regulatory requirements and internal policies.
• Periodically reporting on her/his activities to the direct line manager.
• Identifying potential risks related to PV compliance, organizational processes or resourcing needs.
• She/he proposes and / implement solutions, corrective and preventive actions to mitigate identified risks.
• Contributing to preparing and monitoring of inspections and audits conducted by business partners, Regulatory authorities on a Global Safety departmental level or at the affiliate level.

Key Aptitudes

Qualification

• Pharmacist, or Scientist, or Life science graduate, or Data analyst with PV experience, or Quality graduate with PV experience.

Experience

• At least 5 years of experience within the pharmaceutical industry in the PV field including a minimum of 3 years in case processing on international perimeter, or in PV quality and analysis of data.
• Excellent knowledge of Global PV regulatory requirements (ICH, GVP, FDA and other worldwide guidelines).
• Demonstrated experience in developing and delivering presentations to different levels of management with the ability to tailor the content and level of detail to the audience.

Language

English

IT aptitude

Strong IT proficiency including advanced use of Microsoft Office (especially Excel) and internal reporting tools.

Knowledge of safety databases (Argus, ARISg, other safety database) and Business intelligence (BI) solutions would be an asset.

Leadership skills and aptitudes

• Proven ability to adapt to change and manage cultural change in an evolving as well as dynamic environment.
• Ability to speak forthrightly and encourage others to do the same.
• Ability to make proposals/solutions that benefit the Global Safety in collaboration with the line management.
• Ability to foresee and identify issues and then propose and develop solutions in compliance with the legal requirements.
• Ability to ‘think out of the box’ and propose solutions.
• Ability to learn new skills related to pharmacovigilance regulatory requirement and systems.