Associate Director, Global Vaccine Safety Compliance
See your future through a different lens
**Except where prohibited by applicable state law, this position requires that you be fully vaccinated against COVID-19 unless you need a reasonable accommodation or qualify for an exemption.**
If you find science, speed, and success exhilarating, you have come to the right place.
Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases, including COVID-19, seasonal influenza, RSV, Ebola, MERS, and SARS. Hard-won lessons and significant advances illustrate that our proven technology has tremendous potential to make a substantial contribution to public health worldwide.
Our scientists are committed to developing vaccine candidates for some of the world’s toughest viral threats by utilizing the power of our innovative recombinant nanoparticle vaccine platform. Our vaccine technology combines the power and speed of genetic engineering with the immunogenicity enhancing properties of our Matrix-M™ adjuvant to efficiently produce highly immunogenic particles targeting some of the most pressing viral infectious diseases.
Novavax, Inc. is headquartered in Gaithersburg, Maryland with additional facilities in Uppsala, Sweden and Bohumil, Czech Republic.
The Associate Director, Global Vaccine Safety (GVS) Compliance is responsible for leading and oversight of Pharmacovigilance (PV) quality and compliance activities. These activities may include but are not limited to PV Compliance oversight, audit/inspection readiness, Pharmacovigilance System Master File (PSMF) management, CAPA management, Deviation Management, PV business partner agreements and oversight, PV Intelligence, PV Standard Operating Procedure (SOP) management and operational excellence, PV training and knowledge management, business continuity, as well as oversight of compliance monitoring related to regulatory reporting timelines and Key Performance Indicators (KPIs) for internal PV related activities service provider/vendor activities and overall PV system performance.
Responsibilities may include some or all of the following tasks based on specific job role:
- Lead or manage PV training strategy, needs assessment and implementation across the organization
- Responsible for driving company level GXP training content for GVPs and functions as global level Subject Matter Expert for content
- Responsible for development and oversight of GVS 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 GVS 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 Novavax functional groups to maximize the effectiveness of PV Compliance activities enterprise wide
- Deliver PV specific training to internal and external stakeholders
- Collaborate with QA Training to obtain and evaluate metrics to assess the impact of training programs and compliance
- Advise and support GVS functional groups and other functions within the company with regards 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 GVS training records and documentation concerning the development and maintenance of GVS standards
- Advise and support GVS activities for GPvP, GCP, and GMP audit/inspection activities related to preliminary preparation, internal host support and participates in audit/inspection interviews representing GVS Drive GVS internal inspection readiness plan
- Serves as GVS lead for both internal and business partner pharmacovigilance audits
- Review (GXP) audit/inspection reports and liaises with appropriate personnel both internal and external to GVS to develop appropriate responses and advise on corrective and/or preventative actions to findings
- Provide oversight for documented corrective/preventative actions to ensure timely completion and determine the need for effectiveness checks as applicable
Business Partner/Alliance Partner Engagement
- Initiate, lead, and maintain Pharmacovigilance Agreements with business partners
- Liaises with internal legal/contract representatives and business partners as required to drive PV agreement terms and oversee ongoing compliance to the agreements
- Provide ongoing compliance oversight and issue resolution pertaining to partner agreements
PV System Compliance Management
- Oversee quality control of monthly and annual reporting compliance data
- Oversee and advise junior staff on trending on root causes for late submissions to identify areas for process improvement or possible revisions to training requirements
- Monitor the quality and performance of the Pharmacovigilance System to ensure consistent, effective, and efficient oversight of core pharmacovigilance process and compliance to regulations through the compilation and review of the monthly PV System Performance Report
- Oversee quality control activities to ensure document and data quality for safety related information including but not limited to aggregate reports, RMPs, signal detection reports, and eTMF documents
- Conduct reviews and gap analysis on new Pharmacovigilance regulations, and guidance documents; lead department level impact assessments and produce recommended plans for implementation within the company.
Procedure Document Standards/Document Management
- Provides oversight for development and maintenance of PV related procedures
- Oversees maintenance the Pharmacovigilance System Master File (PSMF) and co-ordinates maintenance of supporting annexes; serves as liaison with business partners to ensure harmonization across companies
- Facilitate lifecycle management of PV procedures in collaboration with other functional areas
- Must have PV (Pharmacovigilance) Audit and Inspection readiness experience and all subsequent activities around audit and inspection.
- Bachelor's degree in healthcare/scientific related fields with 10 years of experience in Pharmacovigilance (PV)/Clinical Research with a minimum of 3 years in PV 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
Novavax offers a base salary, annual bonus, equity grants, professional career development/growth opportunities, and a comprehensive benefits package including medical, dental, vision, Rx, STD, LTD, Life, Optional Life, 401(k) plan.
Equal Opportunity Employer/Veterans/Disabled
Novavax is an equal employment opportunity employer. Employment and advancement opportunities are available to all individuals on an at-will basis, regardless of their race, color, national origin, religion, ancestry, citizenship status, military or veteran status, sex, sexual orientation, gender identity or expression, age, marital status, family responsibilities, pregnancy, disability, genetic information, protective hairstyle, or any other characteristic protected by applicable federal, state, or local law.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Gaithersburg, Maryland, USA
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