Senior Manager, Global Vaccine Safety Compliance

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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.

Summary of the Position:

The Senior Manager, Global Vaccine Safety (GVS) Compliance is responsible for managing and/or leading 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 activities 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:

Training

  • Responsible for leading 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)
  • Manages company level GXP training content for GVPs and may function as global level Subject Matter Expert for content
  • Oversees 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 training compliance

Audit/Inspection Readiness

  • Responsible for ensuring the accuracy, completeness, and audit readiness of GVS training records and documentation concerning the development and maintenance of GVS standards
  • Leads and/or manages GVS 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.
  • Manages =implementation of GVS internal inspection readiness plan
  • Serve as GVS point of contact or lead for input coordination support 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
  • Manages follow up on documented actions to ensure timely completion and assist in determining the need for effectiveness checks as applicable

Business Partner/Alliance Partner Engagement

  • Creates and maintains Pharmacovigilance Agreements with business
  • Liaises with internal legal/contract representatives as required to establish PV agreement terms and oversee ongoing compliance to the agreements
  • 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
  • Manage ongoing oversight and issue resolution pertaining to compliance to partner agreements

PV System Compliance Management

  • Lead and/or manage 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
  • Monitors 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
  • Conducts reviews and gap analysis on new Pharmacovigilance regulations, and guidance documents; manages department level impact assessments and produces recommended plans for implementation within the company

Procedure Document Standards/Document Management

  • Manage or leads development and maintenance of PV related procedures
  • Maintain 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

Minimum Requirements:

  • Bachelor's degree in healthcare/scientific related fields with 8-10 years of relevant experience in Pharmacovigilance (PV)/Clinical Research with a minimum of 2 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
  • 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 in English
  • 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

Preferred Qualifications:

  • Experience in leading standards and/or training organizations within the pharmaceutical industry highly desired
  • Strong attention to detail and persistence in following tasks through to completion
  • Proficiency with standard office software (Microsoft Office)

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.

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.

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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)

Job details
Clinical
Remote - US
Gaithersburg, Maryland, USA
SENIO003950
Full-time
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