Pharmacovigilance Quality & Training Senior Specialist

Job Description

The Position

Position Overview: Organon is a new company with the need to streamline processes and improve comprehensive overview on the pharmacovigilance (PV) system, to monitor quality and compliance, as well as to collaborate successfully within the organization and with business partners.

The Sr. Specialist, PV, Quality Management and Training will support the management and quality of procedural documentation wherein procedures are updated and quality by design is incorporated into the SOP update process. This role will also support the maintenance of the Pharmacovigilance System Master File (PSMF) which will support product registration, renewal and provide an overview of Organon’s PV System. The Sr. PV Specialist will also maintain a robust PV Training system along with the Adverse Event reporting training course. The Sr. PV Specialist will be responsible for procedural document management, update and quality review, PSMF review and update, maintenance of PV system training plans and management of
- wide Pharmacovigilance training (Adverse Event and Product Quality Complaint Reporting). Other tasks include support of GPV or OR&D projects as needed and other responsibilities as assigned by management.

Responsibilities

• Coordinate procedural documentation management (lifecycle, ad hoc, routine review, and maintenance of SOPs)
• Provide technical writing support in update of SOPs
• Perform quality review of documents, keep records for continuous improvement activities
• Coordinate with quality for change control activities; support quarterly publication of the PSMF
• Liaise with subject matter experts across multiple disciplines
• Understand GVP Module II requirements and regulations for updating PSMF
• Have thorough PV knowledge and experience to support PSMF updates
• Support local PSMF publication and liaise with Local Safety Officers
• Quality checks on PSMF content and inspection readiness (ad hoc updates for inspections and audits)
• Support maintenance of PV training plans impacting GPV (including CSO and CMO)
• Develop training material, assessments, and courses within the LMS
• Maintain curricula and keep training plans current
• Generate metrics and compliance checks on training completion (weekly, monthly, or ad hoc)
• Support implementation of
  - wide Pharmacovigilance training (AE /PQC Reporting)
• Follow up with internal and external stakeholders to ensure completion of training and implementation within team matrix
• Generate monthly metrics to review course completion
• Participate in relevant meetings for
  - wide trainings
• Review course content and material for update
  - annually

Competencies

• Understanding and experience in PV regulations
• Experience with GVP Module II and management of PSMF
• Administration, review, and update of training management plans and implementation via the LMS
• Leadership skills in working with all levels of management and consulting with key business stakeholders
• Excellent writing and verbal communication skills, problem solving ability, and analytical skills
• Strong knowledge base of PV regulations,
  - depth understanding of business process, safety systems
• Fluent in written and spoken English

Qualifications

• Analytical and
  - solving skills
• Ability to work effectively across functions and divisions
• Organizational, project, and time management skills
• Ability to efficiently and productively communicate in English orally and in writing

Previous Experience in Pharmacovigilance / ICSR Processing / Regulatory Affairs required

Bachelor’s degree in a life science/health care/pharmaceutical related field

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.

Requisition ID: R537244