Pharmacovigilance Quality & Training Senior Specialist

Pharmacovigilance Quality & Training Senior Specialist

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Position Overview

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

The Senior 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 Senior PV Specialist will maintain a robust PV training system along with the adverse event reporting training course.

Responsibilities

• Coordinate procedural documentation management (lifecycle, ad hoc, routine review, and maintenance of SOPs).
• Provide technical writing support in the update of SOPs.
• Perform quality review of documents and 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 the PSMF.
• Have thorough PV knowledge and experience to support PSMF updates.
• Support local PSMF publication and liaise with local safety officers.
• Conduct quality checks on PSMF content and ensure inspection readiness (ad hoc updates for inspections and audits).
• Support maintenance of PV training plans impacting GPV (including CSO and CMO).
• Develop training materials, assessments, and courses within the learning management system.
• Maintain curricula, learning items, and keep training plans current.
• Generate metrics and 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 within the team matrix.
• Generate monthly metrics to review course completion.
• Participate in relevant meetings for enterprise‑wide trainings.
• Review course content and material for updates semi‑annually.
• Perform any responsibilities or tasks assigned by management.

Qualifications

• Experience in pharmacovigilance, ICSR processing, or regulatory affairs.
• Strong understanding of PV regulations and GVP Module II.
• Experience managing and updating the Pharmacovigilance System Master File (PSMF).
• Experience developing and maintaining training plans via a learning management system.
• Bachelor’s degree in a life‑science, health‑care, or pharmaceutical related field.
• Excellent written and verbal communication skills in English.
• Analytical, problem‑solving, and organizational skills.
• Ability to work effectively across functions and divisions.
• Leadership and collaboration skills with stakeholders at all levels.
• Strong knowledge of safety systems and business processes.
• Ability to produce metrics and compliance checks on training and documentation.

Employment Information

• Seniority level: Mid‑Senior
• Employment type: Full‑time
• Job function: Management and Manufacturing
• Industry: Pharmaceutical Manufacturing
• Job location: Lisbon, Portugal
• Number of openings: 1

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.