This function serves as the European Union Qualified Person for Pharmacovigilance (EU QPPV) and/or global QPPV for allocated projects/clients. This QPPV is part of the global QPPV team in Syneos Health and is directly responsible for multiple projects with special emphasis on establishing and maintaining the pharmacovigilance (PvG) system in accordance with European Union (EU) requirements - including all activities, which contribute to the detection, assessment, understanding and communication of safety information, as well as risk management activities. Oversees the safety profiles for the medicinal products for which the client Company holds a Marketing Authorization in the (EU) and any emerging safety concerns. Acts as a single point of contact for the Regulatory Authorities on a 24-hour basis, and the contact point for PvG inspections. Ensures and verifies that the client’s pharmacovigilance system master file (PSMF) is a continuously accurate and up-to-date reflection of that safety system. The QPPV is directly involved in a variety of tasks related to the global and local PV quality system management. The function will be allocated tasks directly from management and help solve and coordinate the daily needs in the QPPV team and for allocated clients.
- The function acts as the EU QPPV and/or a Global QPPV for assigned Clients and on behalf of them as a single point of contact for the Regulatory Authorities in EU, and potentially outside EU, on a 24-hour basis.
- The QPPV supports safety services beyond clinical development, supporting clients moving into the post-marketing environment, ensuring PV support to the entire life cycle of a product.
- The function contributes to the establishment, implementation and maintenance of clients global pharmacovigilance activities and the continuously development of the QPPV function within Syneos Health.
- The QPPV works closely with the entire project and client team to ensure compliance to the global PV Legislation.
- Overall responsible for establishment, development and maintenance of assigned client’s pharmacovigilance (PVG) system in accordance with requirements - including all activities which contribute to the detection, assessment, understanding and communication of safety information, as well as risk management activities
- Ensures the provision of a comprehensive and compliant Pharmacovigilance service in line with the requirements of Directive 2010/84/EU: Maintains the system, which ensures the information about suspected Adverse Drug Reactions (ADRs) reported to company personnel, is collected and collated within the EU.
- Oversee that processes are in place to ensure all ADRs from Client’s marketed products are entered into the relevant Safety Database and followed up appropriately and that all ADRs are handled in line with global PV requirements (including reporting to the relevant Regulatory Agencies in the required timelines).
- Oversee that processes are in place to ensure all serious adverse events occurring in Clinical Trials for relevant client products within the region are entered into the relevant Safety Database and reconciled with the final studies databases and to ensure all Suspected Unexpected Serious Adverse Reactions (SUSARs) are reported to the relevant Regulatory Agencies in the required timelines.
- Ensure the provision to competent authorities of reports required by the appropriate legislation, including ADR reports, Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Clinical Expert Statements (CES) (as applicable) and review of all company sponsored Post Authorization Safety Study (PASS) reports and protocols.
- Oversee the safety profiles for the relevant products for which the Client Company holds a Marketing Authorization in the (EU) and any emerging safety concerns, and ensure that proper processes are in place to continuously evaluate the benefit-risk profile of the products during the post-authorization period and the provision of full/prompt responses to competent authorities for additional information necessary if needed.
- Overseeing the clients risk management system is updated and that pharmacovigilance data are monitored to determine whether there are any new risks are identified, if already identified risks have changed or if there are changes to the benefit-risk balance of the products.
- The function oversees the outcome of risk minimization measures which are contained in the risk management plan or which may be laid down as a condition of the Marketing authorization.
- The role has the authority to review and change content as well as sign off on aggregated reports including Risk Management Plans (RMPs) and Aggregated Safety Update Reports for relevant client products, and participates in the clients signal detection and evaluation process to ensure that signal detection activities are tracked and actioned as appropriate.
- Contact point for PVG Audit and inspections for clients’ products, and provides input to the planning of clients audits of Pharmacovigilance and remains knowledgeable of the status of the audit plan. Reviews the findings from PV audits and inspections relevant for client and projects allocated.
- Ensures, verifies and have access to the Client’s Pharmacovigilance System Master File (PSMF) and that the file is a continuously accurate and up-to-date reflection of that safety system.
- Oversee that proper Quality Control (QC) and Quality Assurance (QA) mechanisms are in place to keep Client in compliance and that performance Metrics & KPIs on expedited and aggregate reporting and other key operational functions are tracked, monitored and corrected, if needed.
- Responsible for the maintenance of a global Pharmacovigilance system at the respective client including Pharmacovigilance Agreements with affiliates/distributors/partners as needed and agreed/outsourced by client.
- Ensures the requirements for a designated in country Responsible Person for Pharmacovigilance (RPP) are fulfilled as required by local regulations either by nominating a suitably qualified and experienced individual in country or by assuming this responsibility personally.
- Ensures all Technical Agreements for relevant parties (vendors, distributors, affiliate etc.) within the EU and for countries designated by the client adequately address all pharmacovigilance responsibilities.
- Reviews and give input to all Standard Operating Procedures (SOPs) pertaining to allocated client(s) PV function and related activities at Syneos Health as needed.
- Provides training on the principles of safety including but not limited to the QPPV function and related legislation, but also ICSR collection or Safety reporting, deviation and CAPA management PV terminology and or PSMF training to ensure compliance and correct understanding of the PV requirements as needed.
- Oversee that PV training related to reporting of safety information, at both local and global PVG levels where safety matters may arise is identified and scheduled.
- Present (as speaker, round-table facilitator, etc.) at when suitable opportunities arise.
- Ensure that outcomes from PV audits are properly monitored, that a quality management system (QMS) is in place to monitor the progression of PV Deviations and PV Corrective and Preventive Action plans (CAPAs) as well as status on PV audit and Inspections for relevant clients.
- As appropriate and with adequate supervision, the QPPV may delegate any task within their remit.
- Travel for client meetings, audit and inspections as well as representation will be required (up to 25%).
- Degree (Bachelors/Masters) in medicine, pharmacy or life science related discipline preferred or equivalent combination of education and experience.
- Reside in the EU.
- Demonstrate expert knowledge in pharmacovigilance legislation, skilled in all aspects of pharmacovigilance.
- Significant experience in the Pharmaceutical Industry required, including relevant PV experience and more broadly exposure to pharmaceutical development.
- Familiar with building, correcting and maintaining global and local PV systems.
- Exposure to and knowledge of PSMF, SDEAs, RMPs, PSURs and other QPPV related activities.
- Knowledge and understanding of pharmacological and medical terminology.
- Development and/or implementation of process improvement initiatives.
- Computer/IT skills (e.g. Word, Excel, Outlook, SharePoint).
- Business level proficiency in English and local language.
- Strong interpersonal and presentation skills; exhibits professional maturity, confidence, and competence. Knows how to summarize and communicate the key points and business case for others to effectively and expeditiously make important decisions.
- Excellent organization skills and sense of urgency/working to tight timelines.
- Structured with a high attention to details.
- Demonstrated ownership of projects and tasks.
- Have a flexible approach.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.