Senior Specialist Drug Safety - QPPV Governance

1w1 week ago

Organon

Lisbon, PT · Full-time · €50,000 – €75,000

About this role

Organon is a new company streamlining pharmacovigilance (PV) processes to monitor quality, compliance, and collaboration. The Senior Specialist Drug Safety – QPPV Governance supports management and quality of procedural documentation. Procedures are updated with quality by design in the SOP process.

This role maintains the Pharmacovigilance System Master File (PSMF) for product registration, renewal, and PV system overview. Responsibilities include coordinating SOP lifecycle, ad hoc reviews, technical writing support, and quality reviews. It involves change control with quality and quarterly PSMF publications.

The specialist develops and maintains PV training plans, including materials and assessments in the Learning Management System. They manage company-wide training on Adverse Event and Product Quality Complaint Reporting. Tasks include metrics generation, compliance checks, and semi-annual content reviews.

Liaise with Subject Matter Experts, Local Safety Officers, and stakeholders across disciplines. Participate in GPV or OR&D projects and handle assigned tasks. Ensure GVP Module II compliance and inspection readiness for PSMF.

Requirements

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

Responsibilities

Coordinate procedural documentation management including lifecycle, ad hoc, routine review, and maintenance of SOPs
Provide technical writing support in update of SOPs and perform quality review of documents
Support quarterly publication of the PSMF and liaise with Subject Matter Experts for updates
Maintain PV System training plans impacting GPV including development of training material and assessments
Manage company-wide Pharmacovigilance Training on Adverse Event and Product Quality Complaint Reporting
Generate metrics and perform compliance checks on training completion
Support local PSMF publication and quality checks for inspection readiness
Participate in GPV or OR&D projects or initiatives as needed