GRAPS Patient Safety Operations, Post Marketing Manager In this role you safeguard patient safety worldwide by leading post-marketing pharmacovigilance operations across Chiesi's global portfolio. You ensure data quality, compliance and safety data integrity while collaborating with international stakeholders to drive continuous improvement and inspection readiness. You will oversee global PV processes, elevate vendor governance, and support audits and CAPAs.
This position sits at the core of a mission-driven R&D; organization focused on sustainable medicine and patient well-being.
pension private medical insurance relocation support remote work options
Support the Safety Operations PM Head to embed regulatory requirements into processes and procedures
Oversee data collection aligned with safety strategy and ensure timely, high-quality post-marketing safety data delivery
Supervise literature safety evaluation at global and local levels
Oversee company-sponsored digital channels and social media related to safety
Engage customers, affiliates and stakeholders across functions and regions
Participate in interdepartmental meetings and act as subject-matter expert for PV activities
Ensure data reconciliations with affiliates and contractual partners; train internal and vendor staff
Support PV service providers (PVSPs) Case Management activities and interact with Safety Science inputs
Supervise PV operations-relevant documentation for ODCS PV topics and contract clauses
Oversee PV activities with CROs, including reconciliations and governance of PV agreements
Ensure PSMF data integrity; manage deviations and CAPA plans
Prepare for and support GVP audits/inspections; lead interviews and CAPA follow-ups
Lead process improvement initiatives within the GRAPS department
Maintain regulatory, policy and procedure compliance
Degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related field
Solid experience in Pharmacovigilance Operations in pharma/biotech/healthcare
Strong knowledge of global pharmacovigilance regulations and GVP
Experience managing safety data collection, quality, and timely reporting
Proven ability to work with cross-functional and international stakeholders
Excellent communication, influencing and stakeholder engagement skills
Experience with external vendors and service providers and ensuring oversight
Strong analytical, problem-solving and continuous improvement mindset
Experience supporting audits, inspections or compliance activities in a regulated environment In this role you safeguard patient safety worldwide by leading post-marketing pharmacovigilance operations across Chiesi's global portfolio....
📌 GRAPS Patient Safety Operations, Post Marketing Manager (Parma)
🏢 Altro
📍 Parma