Director, Pharmacovigilance Quality Business Partner - REMOTE

Job Description

The Director, Pharmacovigilance (PV) Quality Business Partner establishes and drives a strategy for sustaining global and local quality and compliance in the routine performance of pharmacovigilance and safety management for all products within our Company's portfolio of drugs, medical devices, and combination products that are commercialized or in development across all geographies. This role is the primary interface between our Company's Quality and Control (Q&C) team and the Global Pharmacovigilance and Safety Science (GPSS) team, including the Chief Safety Officer. This role reports directly to the Executive Director, Quality Business Partner for Regulatory Affairs and Pharmacovigilance.

Primary Responsibilities:

• Develop/oversee execution of (end-to-end) PV processes and systems to ensure compliance/alignment with regulatory requirements and internal policies/procedures.

• Ensure change control for all PV procedural documents, including robust impact analyses and training programs prior to implementation.

• Ensure audit and inspection readiness, including preparation of internal and Business Partner audits and regulatory inspections.

• Ensure quality by design and adherence to GxP principles in the research and development of assets in our Company's Research and Development (R&D) portfolio, as assigned.

• Participate in due diligence and integration of new (potential) portfolio assets, as assigned. Ensure compliance and inspection readiness throughout the integration process.

• Drive accountability within GPSS for timely self-identification of quality issues and timely completion of robust investigations and CAPA within the PV QMS.

• Foster a culture within our Company that prioritizes quality and compliance in consideration of everything we do.

• Review and approve procedural documents and associated training plans, ensuring proper change control.

• Serve as a core member of the Business Process Owner network as the QBP for the PV procedural framework.

• Work directly with GPSS and other ORD stakeholders to ensure timely and proper execution of investigations and appropriate CAPA actions that will maintain the integrity of the procedural framework and inspection readiness.

• Escalate risks and issues to the Quality Council as required.

• Establish and lead a regular schedule of meetings with GPSS LT (and other stakeholders) to review the performance of the organization against established key quality indicators and drive actions to improve performance, as necessary.

• Participate in PV-related inspections of Organon to ensure clear and concise information about the PV system is provided to inspectors. Inspection tasks may include identifying Organon subject matter experts, working with GPSS to develop inspection responses and preparing storyboards, interfacing directly with inspectors as the inspection host, and/or ensuring appropriate CAPA commitments are developed in response to findings.

• Support study team/ADT activities for assigned portfolio assets.

• Support business development teams in due diligence and integration, as assigned.

• Participate in regulatory intelligence and surveillance activities for emerging regulations in any geography that may impact our Company's PV system.

• Assist in the development and maintenance of a business continuity plan for our Company's PV system and Q&C team.

Education Minimum Requirements:

• Bachelor's degree or equivalent in a scientific or technical field related to the healthcare/pharmaceutical industry, or licensed Healthcare Professional degree (such as RN, RPh., PA).

Required Experience and Skills:

Professional:

• Expert - communication (verbal and written).

• Advanced – leadership, self-awareness, interpersonal.

• Advanced – strategic (big picture oriented) with attention to detail.

Technical:

• Advanced – Good Pharmacovigilance Practices; international pharmaceutical regulations.

• Advanced – International medical device and combination product safety surveillance and reporting regulations.

• Advanced – knowledge of quality management systems, procedural frameworks, change control.

• Advanced – understanding/experience with health authority inspections.

• Advanced – ability to analyze data to create and present visualizations of organizational performance; ability to drive and oversee completion of actions to improve performance based on these metrics.

• General Microsoft applications.

• Workflow-based IT system applications.

• Dynamic data-based dashboards.

Experience:

• 10+ years of experience in medical device and/or pharmaceutical industry.

• 5+ years in jobs related to safety surveillance or pharmacovigilance.

• 3+ years in roles interfacing directly with senior leaders.

• 3+ years in Quality & Compliance-based roles.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

For more information about personal rights under Equal Employment Opportunity, visit:

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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

Search Firm Representatives Please Read Carefully
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R519027