Pharmacovigilance Manager
Pharmacovigilance Manager
Rotterdam
Netherlands
£100,000/year
Permanent
Medical & Regulatory Affairs
Senior PV Manager
As the PV Manager, you will lead pharmacovigilance activities for our nasal spray product portfolio, ensuring drug safety and regulatory compliance. You will oversee safety monitoring, risk management, and regulatory reporting while collaborating with cross-functional teams.
Key Responsibilities
PV System Management
* System Oversight: Organize, manage, and maintain a robust and compliant Pharmacovigilance system that meets all regulatory requirements.
* Process Documentation: Ensure all internal regulatory/PV processes and procedures are thoroughly documented and support compliant regulatory/PV activities.
* Regulatory Adherence: Maintain awareness of and ensure adherence to national PV regulations and guidelines, including Good Pharmacovigilance Practices (GVP).
Audits and Inspections
* Audit Coordination: Coordinate internal and external PV audits and inspections, ensuring preparedness and compliance.
* Inspection Readiness: Develop and implement strategies to ensure continuous inspection readiness and address any findings promptly.
Compliance Monitoring
* Performance Monitoring: Monitor the performance and compliance of the PV system, including partners and distributors, to ensure adherence to established standards.
* Compliance Reporting: Generate regular compliance reports and metrics to track the effectiveness of the PV system.
Training and Development
* Training Programs: Organize and coordinate comprehensive vigilance training programs for internal teams and external partners.
* Continuous Education: Ensure ongoing education and training on PV regulations, processes, and best practices.
Adverse Reaction Reporting
* System Oversight: Oversee the adverse reaction reporting system, including the collection, receipt, triage, assessment, processing, and regulatory reporting of adverse events.
* Data Integrity: Ensure the accuracy and completeness of adverse event data and timely submission to regulatory authorities.
Regulatory Actions and Documentation
* Regulatory Submissions: Ensure the submission of all pharmacovigilance-related documents and data in accordance with legal requirements and GVP.
* Safety Concerns: Provide input on the preparation of regulatory actions in response to emerging safety concerns, such as safety variations, urgent safety restrictions, and communications to patients and healthcare professionals.
* Key PV Documents: Contribute to the preparation and maintenance of key PV documents, including Risk Management Plans (RMPs), Safety Data Exchange Agreements (SDEAs), Summary of Product Characteristics (SPC) updates, and Pharmacovigilance System Master Files (PSMF).
Qualifications
* Educational Background: Master’s degree in pharmaceutics, healthcare, life sciences, or related fields.
* Experience: Minimum 2 years of experience in a similar pharmacovigilance role.
* Regulatory Knowledge: In-depth knowledge of relevant EU and national legislation relating to medicines and expert knowledge of good pharmacovigilance practices (GVP).
* QPPV Tasks: Demonstrated experience with Qualified Person for Pharmacovigilance (QPPV) tasks, including RMPs, SDEAs, SPC updates, and PSMFs.
Skills
* Analytical Skills: Strong analytical and problem-solving skills with a keen attention to detail.
* Communication: Excellent verbal and written communication skills, with the ability to convey complex information clearly and concisely.
* Interpersonal Skills: Effective interpersonal skills to collaborate with cross-functional teams and external stakeholders.
* Leadership: Proven leadership and team management abilities, with experience in mentoring and developing staff.
* Project Management: Strong organizational and project management skills, with the ability to manage multiple projects simultaneously.
* Technical Proficiency: Proficiency in PV databases, data analysis tools, and relevant software.
Key Performance Indicators
* Regulatory Compliance: Ensure full compliance with PV regulations and timely reporting of adverse events.
* Audit Success: Achieve successful outcomes in PV audits and inspections.
* Training Effectiveness: Implement effective PV training programs with measurable improvements in team knowledge and performance.
* Timely Submissions: Ensure timely and accurate submission of all PV-related documents and data.
* Safety Communication: Provide timely and effective input on safety-related regulatory actions and communications.
Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.
Ryan Griffin
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