GRAPS Patient Safety Operations, Post Marketing Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b2hy0

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....

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7b2hy0