Job Description
Position Overview
The Associate Director, Global QPPV Office, supports the Qualified Person for Pharmacovigilance (QPPV) in overseeing the functioning of the Pharmacovigilance (PV) System, including the related Quality System, and supports any actions required to address deficiencies in the system in relation to applicable PV legislation in the EU and globally. In addition, participates in cross functional activities and initiatives on process related matters and leads continuous improvement projects relevant to Pharmacovigilance deliverables, ensuring compliance with company policies, procedures, and regulatory requirements.
Organizational Relationships:
Reports to the Associate Vice President, European Union Qualified Person for Pharmacovigilance (EU QPPV) & Head of Global QPPV Office, Global Pharmacovigilance.
Primary Responsibilities
- Support the Head Global QPPV Office in the maintenance of the Global QPPV Office-led forums.
- Contribute to Organon’s PV system oversight and supports the Head Global QPPV Office and EU QPPV with delegated tasks.
- Lead the Global QPPV office representation in internal and external audit activities related to the PV system oversight.
- Support inspection readiness and activities, including preparation and response review.
- Monitor and interpret compliance practices and their impact on the PV system.
- Assess and manage risk to the PV system, including input into the annual audit program.
- Escalate issues impacting the PV system with proposed mitigation strategies.
- Work closely with cross functional stakeholders and subject matter experts within Global Pharmacovigilance, Quality and Compliance, and other functions such as Regulatory Affairs, Medical Affairs, etc., to address and resolve issues relating to PV processes.
Tasks
- Contribute to the development and continuous improvement of the components of the global and local country PV Systems and their interactions, in accordance with applicable regulatory requirements.
- Take ownership of corrective and preventive actions (CAPAs) that are the responsibility of the Global QPPV Office, as assigned.
- Support and participate in PV audits and inspections preparation and attendance, as needed.
- Assist in preparing and responding to requests from PV Regulatory Agency Inspections as well as internal and external audits.
- Review audit and inspection reports and provide feedback to the Global QPPV Office
- Lead and participate in PV and cross-functional projects, on behalf of the Global QPPV Office.
- Providing an independent and objective compliance and quality overview of the pharmacovigilance system across geography to support the QPPV (EU/Global) oversight.
- Acting as the interface between GPV and other functions, particularly in the implementation of pharmacovigilance activities.
- Collaborate internally and externally on processes that ensure compliance with regional and global PV regulations.
- Represent the EU QPPV in vendor oversight, ensuring compliance with Pharmacovigilance Agreements (PVAs).
- Prepare, analyze, and communicate compliance metrics and significant compliance information to the QPPV and/or PV leadership forums.
- Proactively monitor for gaps in the PV system and discuss appropriate remedial actions with the Head Global QPPV Office.
- As needed, propose improvements to existing processes and metrics to streamline compliance oversight.
- Participate in internal and external groups for networking, intelligence gathering and input.
- Support the design, implementation, and continuous improvement of the PV Intelligence process, including analysis and contextualization of best practices and trends across industries, emerging regulations and legislation, new technologies, capabilities, and partners.
- Support the EU QPPV/Deputy QPPV(s) for the preparation, conduct and follow-up actions for EEA Regulatory Authority inspections and audits.
- Support the EU QPPV/Deputy QPPV(s) having oversight on PV audit and inspection strategy, scheduling, and significant findings.
Competencies
- This role demands both strategic oversight and hands-on engagement with detailed operational activities, reflecting a need for versatility and adaptability.
- Project management (or equivalent) competencies are required and proven capacity to work in a matrix organization.
- Demonstrates ability of coordinating multi-functional activities in a highly regulated environment resulting in concrete business results
- Communication- both verbal and written in a credible and effective way
- Excellent interpersonal skills, and a high level of personal integrity.
Qualifications / Skills (professional and/or technical)
- Demonstrates strong communication and relationship building skills.
- Demonstrated ability to work effectively across functions and divisions and
- influence process and decisions at a senior management level.
- Organizational excellence and project management skills
- Displays strong organization and time management skills; reliable in completing tasks and delivering on commitments in a timely manner.
- Details oriented with strong analytical, prioritizing, interpersonal, problem-solving, & planning skills
- Demonstrated networking skills – including ability to interact with internal staff.
- Results oriented with good listening, conflict resolution, negotiation, and interpersonal skills.
- Ability to identify and implement process and/or application improvements.
- Collaborative and curious with ability to work in an environment of rapidly changing priorities and workload; ability to manage multiple activities and assignments.
- Proficient knowledge of MS Office products, specifically Share Point administration, Word, Excel, PowerPoint, Visio, MS Project.
- Strong verbal and written communication skills
- Fluent in English – both verbal and written
Experience
- Good knowledge of International PV legislations and GVP
- Experience and/or good understanding of the complexities of a PV System
- Experience and expertise in pharmacovigilance processes and compliance monitoring.
- Regulatory experience in industry or a main Health Authority would be of value.
- Demonstrated experience of working with business partners, vendors / third party providers highly desirable.
- Experience networking and interfacing with external pharmacovigilance stakeholders and peers.
- Demonstrated experience of implementing cross-functional partnerships and business processes
Education / Certificates
- 10+ years of relevant PV experience.
- Bachelor’s degree in medicine, life sciences, health or related field required.
- Advanced degree e.g., Masters, PharmD., Ph.D., MD preferred
Secondary Job Description
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.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
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.
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.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Regular
Relocation:
No 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:
1
Requisition ID:R528507
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