Provides operational support for the QPPV Office Function within the Safety & Pharmacovigilance Business Unit (BU). Support may concentrate in one or multiple areas including but not limited to Pharmacovigilance Safety Master File (PSMF), Safety Data Exchange Agreement (SDEA), PV System build and/or enhancement, PV Quality and Compliance monitoring or CAPA support, PV training and PV audit and inspection readiness. Support and guide on PV projects requirements for “lab-to-life” customers and to other project team members to deliver relevant PV objectives in relation to global PV system provision as required for a MAH after pre-or post-approval of their medicinal product.
- Assist the assigned QPPV team in relation to various tasks, meetings and deliverables in relation to specific allocated projects.
- Provide input to proposals and project budgets.
- Participate in the generation and maintenance of quality documents as needed (Policies, SOPs, Charters, Agreements, etc.) in Syneos or in relation to allocated projects.
- Mentor and train global and local PV and non-PV staff to ensure knowledge sharing and in relation to PV processes and required quality, legislation and compliance.
- Liaise with local Safety officers in allocated projects as needed and where required assume vendor management activities for any outsourced post-marketing services included via Syneos Health in global assigned projects.
- Draft, analyze and help develop safety and pharmacovigilance documents as needed to ensure overall project compliance.
- Maintains continuous knowledge and expertise in GVP requirements for pre- and post-marketing pharmacovigilance to ensure sufficient update- to-date advisory skills.
- Support and guide relevant client members and other project team members to deliver relevant objectives in relation to the SDEA including but not limited to safety training, inspection readiness and PV system set-up and PSMF deliverables.
- Performs other work-related duties as assigned.
- Assigned as primary responsible for delivering the Client PSMF.
- Overall responsible for supporting and coordinating the PSMF including all stages in the built, registration and maintenance of the assigned client’s Pharmacovigilance System Master File(s).
- Draft and finalize all documents associated with the PSMF process and facilitate all review processes and approvals.
- Maintain PSMF Repository for allocated projects.
- Assist the QPPV Office team to ensure delivery and updates to the client’s PSMF. Ad hoc and upon urgent request.
- Act as a quality and compliance specialist in the post approval PV area
- Interact directly with clients to collate information for PSMF.
- Implement the PSMF outlined KPIs in client’s PV systems.
- Perform Maintenance of the PV system in Syneos Health and provide attention to detail with allocated client’s quality documents and processes as they related to the PV Quality system.
- Support in enhancement of the PV Quality system for allocated projects as needed.
- Draft, update, and author PV Corrective and Preventative action (CAPA) plans to ensure correct reflection of open findings and deviations in the PSMF and when needed work on associated changes or updates to the Syneos Health or client procedures whichever apply.
- Can act as lead operational PV CAPA support for clients identified deviations or findings to enhance their PV quality System.
- Lead or support gap analysis of client pharmacovigilance systems.
- Assigned as primary responsible SDEA Specialist to specific projects and is responsible for ensuring that the client SDEAs are in place and the components included in the SDEAs are updated and prepared according to plan, procedures, and legislation to ensure compliance.
- Complete contractual review and manage Client/customer third Party agreements, or draft new or update existing contracts, with respect to pharmacovigilance and the exchange of safety data.
- Arrange meetings to overall coordinate negotiate and finalize the client’s third Party Agreements to ensure finalization and implementation.
- Maintain contractual overview for the assigned clients when relevant in relation to SDEA oversight.
- Participate in internal improvements of the Syneos SDEA processes and SDEA templates covering the post marketing PV system.
- Interact directly with clients, their third parties, including their respective operational teams and legal stakeholders, to collate, update or clarify information for the contracts & agreements including SDEAs as needed.
- Implement the finalized SDEA and train all involved parties responsible for safety activities and timelines outlined in the SDEA.
- Act as contact point for business partners, other departments, third party provider(s), authorities and other partners regarding SDEAs for allocated projects.
- Draft, update, and author PV corrective and preventative action (CAPA) plans when related to the SDEA area or other area as defined in the SDEA template.
- Act as SDEA SME and go-to point of contact for allocated projects.
- Minimal travel may be required (up to 25%).
- BA/BSc. in life sciences, Registered Nurse (RN), pharmacist or equivalent combination of education and experience or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job
- Exposure to and knowledge of QPPV related activities
- Very structured and detail-oriented with an excellent ability to keep the overview of complex projects.
- Excellent communication skills including written and verbal communication.
- Excellent understanding of post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance.
- Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet. Basic MS Project skills are preferred.
- Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills.
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.