At a Glance
- Tasks: Support pharmacovigilance activities and ensure compliance across the EMEA region.
- Company: Join a leading pharmaceutical company dedicated to patient safety.
- Benefits: Flexible hybrid work, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with mentorship opportunities and involvement in special projects.
- Why this job: Make a real impact on drug safety and collaborate with experts in the field.
- Qualifications: Experience in pharmacovigilance and strong communication skills required.
The predicted salary is between 50000 - 65000 £ per year.
- Job
- Title: Regional PV Officer – EMEA Role
Summary: The Regional PV Officer supports and oversees pharmacovigilance activities across the EMEA region, working closely with PV Regional Head, cluster leads, PV leads and country teams.
He/she is a subject‑matter expert for regional and global PV initiatives and collaborates with global GCS&PV colleagues and other functional areas.
Responsibilities
- Support the implementation, maintenance, and continuous improvement of the IPV Quality Management System (QMS) in line with global standards.
- Provide expert guidance to country PV teams on pharmacovigilance matters, ensuring alignment with global processes and local regulatory requirements.
- Support audits and inspections, including readiness activities and execution.
- Lead CAPA management of country PV audits and facilitate CAPA development.
- Share knowledge on reportability rules and other reference data updates in the Global Safety Database.
- Interact with Country PV and GCS&PV staff to ensure regional application of global standards and systems.
- Execute regionally required pharmacovigilance submissions (e. g., EUCTR DSURs) and ensure compliance with timelines and regulatory needs.
- Provide guidance on complex cross‑functional scenarios and develop innovative solutions for operational PV matters.
- Perform compliance monitoring of individual case safety reports and aggregate reports, leading investigations when needed.
- Coordinate translation of PV documents when applicable.
- Prepare, review, and maintain local, regional, and global IPV procedures, owning procedural documents as needed.
- Serve as documentation steward for the IPV organization, ensuring accuracy and timely updates.
- Support compliance activities such as issue management and self‑inspection.
- Manage contractual activities related to PV agreements, including language inclusion, due diligence, and compliance reviews.
- Monitor and interpret PV legislation updates, supporting intelligence activities.
- Gather pharmacovigilance information from local operations and assist in summarising it.
- Ensure PSMF or CCPD process updates, liaising with relevant stakeholders.
- Support compliance metrics and establish key performance indicators.
- Execute IPV training strategy and maintain training curricula.
- Represent IPV in regional, cluster, and global meetings, supporting planning and facilitation.
- Serve as backup to PV Lead or IPV roles during absences.
- Participate in special projects or rotational assignments for professional development.
- Mentor PV staff on pharmacovigilance topics.
- Complete all required trainings on time and comply with regulations, internal procedures, and company policies.
- Required Skills
- Adverse Event Report
- Contract Management
- Drug Safety Surveillance
- Pharmaceutical Regulatory Compliance
- Pharmacovigilance
- Quality Standards
- Regulatory Reporting
- Regulatory Requirements
- Risk Management
- Strategic Planning
- Preferred Skills
- None specified.
- Employment Details
- Employee
- Status: Regular
- Relocation: No relocation VISA Sponsorship: No
- Travel
Requirements: 10% Flexible
- Work
- Arrangements: Hybrid
- Valid
- Driving
- License: No
- Hazardous
- Materials: N/A
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Regional Pharmacovigilance Officer employer: MSD Malaysia
MSD Malaysia is an exceptional employer that values innovation and collaboration, offering a dynamic work culture where employees can thrive. With a strong commitment to professional development, the company provides ample opportunities for growth and engagement in meaningful healthcare initiatives across Scotland and Northern Ireland. Employees benefit from a supportive environment that encourages scientific excellence and fosters lasting relationships with key opinion leaders in the medical field.
