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 global experts.
- Qualifications: Experience in pharmacovigilance and strong regulatory knowledge 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
- #J-18808-Ljbffr
Regional Pharmacovigilance Officer in London 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.
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We think this is how you could land Regional Pharmacovigilance Officer in London
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We think you need these skills to ace Regional Pharmacovigilance Officer in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at MSD Malaysia!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show MSD Malaysia that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at MSD Malaysia!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At MSD Malaysia, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at MSD Malaysia
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at MSD Malaysia that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with MSD Malaysia’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
