Sr. Specialist Drug Safety - QPPV Governance

Job Description

Job Description: Sr. Specialist Drug Safety – QPPV Governance

Although one or more potential candidates for this position have been identified, we will consider applications from any interested applicants.

The Position

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, Drug Safety – QPPV Governance 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 - Management of Company-wide Pharmacovigilance Training (Adverse Event and Product Quality Complaint Reporting) - Participate in or support any other GPV or OR&D projects or initiatives as needed - Any responsibilities or tasks 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)

- Development of training material, assessments, and courses within the Learning Management System 

- Perform maintenance activities to update curricula, learning items, and keep training plans current Generation of metrics, compliance checks on training completion (weekly, monthly, or ad hoc)

- Support the implementation of company-wide Pharmacovigilance training (AE /PQC Reporting training course)

- Follow-up with internal and external stakeholders to ensure completion of training and implementation of training within team matrix

- Generation of monthly metrics to review course completion

- Participate in relevant meetings for enterprise-wide trainings

- Review course content and material for update semi-annually 

Required Education, Experience, and Skills

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, in-depth understanding of  business process, as well as safety systems Fluent in written and spoken English

Qualifications

Skills

- Analytical and problem-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

Experience

Previous Experience in Pharmacovigilance / ICSR Processing / Regulatory Affairs  required 

Education

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

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 he