Senior Manager/Associate Director, Pharmacovigilance Compliance

Company: System One
Location: Gaithersburg
Posted on: February 25, 2021

Job Description:

Senior Manager/Associate Director, Pharmacovigilance Compliance Job Title: Senior Manager/Associate Director, Pharmacovigilance Compliance

We are seeking a motivated and experienced individual to serve as Sr. Manager/Associate Director, Pharmacovigilance Compliance in support of a growing number of clinical stage vaccine development programs. The focus for this position is coordinating and leading a variety of Pharmacovigilance (PVG) quality and compliance activities related to Training, Standards and Compliance Management.-- Responsibilities include but are not limited to:

• Responsible for development and co-ordination of Product Safety & PVG department new hire induction and role-based training plans.--
• Responsible for driving the development and approval of pharmacovigilance training materials and programs both internal and external to the Product Safety & PVG organization (i.e. Vendors--and--collaboration partners).
• Works with QA Training to develop and produce metrics to assess the impact of training programs. Liaise with representatives from other functional groups to maximize the effectiveness of PV Compliance activities enterprise wide.--
• Advises and supports Product Safety functional groups and other functions within the company with regard to pharmacovigilance regulations, guidelines and standards (including audit/inspection readiness) to optimize departmental quality, standards, and training.--
• Responsible for ensuring the accuracy, completeness, and audit readiness of PVG training records and documentation concerning the development and maintenance of PVG standards.
• Supports Product Safety & PVG activities for GPvP, GCP, and GMP audit/inspection activities related to preliminary preparation, internal host support and participates in audit/inspection interviews representing Product Safety.
• May serve as Product Safety & PVG lead or provide coordination support for business partner pharmacovigilance audits.--
• Reviews draft (GXP) audit/inspection reports and liaises with appropriate personnel both internal and external to Product Safety & PVG to develop or recommend corrective actions to findings and conducts follow up on documented actions to ensure that they are completed and documented successfully within set timelines.--
• Creates and maintains Pharmacovigilance Agreements with business partners. Liaises with internal legal/contract representatives as required.
• Performs quality control of monthly and annual reporting compliance data and performs trending on root causes for late submissions to identify areas for process improvement or possible revisions to training requirements.--
• Monitors the quality and performance of the Pharmacovigilance System to ensure consistent, effective and efficient oversight of core pharmacovigilance process through the compilation and review of the monthly PV System Performance Report.
• Maintains the Pharmacovigilance System Master File (PSMF) and co-ordinates maintenance of supporting annexes; serves as liaison with business partners to ensure harmonization across companies.--
• Conducts reviews and gap analysis on new Pharmacovigilance regulations, and guidance documents; produces recommended plans for implementation within the company and is responsible for creating and delivering training.--
• Assists with other PV compliance activities as required.
• Bachelor's degree in healthcare/scientific related fields.
• Minimum of 7 years of relevant experience in Pharmacovigilance/Clinical Research with a minimum of 3 years in PVG compliance and quality. A proven track record in pharmacovigilance with several examples of leading pharmacovigilance related compliance activities.
• Demonstrated ability to apply principles, concepts and industry best practices governing pharmacovigilance in assigned projects and company deliverables.
• In depth knowledge of global safety reporting activities, regulations, ICH/GXP guidelines, and pharmaceutical industry compliance practices and be able to provide guidance regarding regulatory requirements internally to Patient Safety and externally to other functions.
• Experience in development of standards and training strategies within pharmaceutical industry and experience of negotiation of safety agreements with business partners.
• Experience in leading standards and/or training organizations within the pharmaceutical industry highly desired.
• Excellent knowledge of international regulations and guidance documents as related to worldwide reporting requirements, preparation of post marketing spontaneous and clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports.
• Excellent written and verbal communication skills.
• Strong interpersonal skills and ability to manage, motivate and influence work behaviors of individuals who are not direct reports.
• Highly organized, outcome oriented, problem solving, understanding of research methods and basic data analysis, excellent teamwork, and strong communication skills; including CAPA management.
• Strong attention to detail and persistence in following tasks through to completion.
• Proficiency with standard office software (Microsoft Office).
• Excellent verbal and written communication skills in English.

Keywords: System One, Washington DC , Senior Manager/Associate Director, Pharmacovigilance Compliance, Executive , Gaithersburg, DC