GRAPS Patient Safety Operations, Post Marketing Manager

This is what you will do

Play a key role in safeguarding patient safety worldwide by leading post-marketing pharmacovigilance operations across Chiesi’s global portfolio. You will ensure the quality, compliance, and integrity of safety data, collaborate with international stakeholders, and drive continuous improvement, inspection readiness, and operational excellence across global Patient Safety processes.

You will be responsible for

•           Support the GRAPS Safety Operations PM Head in ensuring that all current requirements for these activities are effectively incorporated into Chiesi processes and documented in procedures

•           Ensure data collection in alignment with the safety strategy for Chiesi products, from any possible source, assessment and delivery of high-quality postmarketing safety data in a timely manner, ensuring that it is correct, consistent (including reconciled), compliant and delivered to agencies

•           Provide oversight of the evaluation of scientific literature at both global and local level to identify case safety reports

•           Provide oversight of Company sponsored controlled websites/Apps and other social media

•           Actively engage applicable customers, affiliates and other stakeholders

•           Participate to interdepartmental meetings inside and outside R&D

•           Act as the primary source of subject-matter expertise to address any questions from Chiesi staff or from external contacts regarding these activities and processes, being responsible for implementing requirements, trainings, procedures maintenance and vendor oversight

•           Guarantee data reconciliations with affiliates and contractual partners

•           Provide appropriate training of relevant internal and vendor staff for these processes, as applicable

•           Support the Case Management team for activities performed by Pharmacovigilance Service Providers (PVSPs)

•           Interact with the Safety Science team for product-specific safety strategy data collection inputs

•           Supervise and/or review of PV operations-relevant sections of documents pertinent to ODCS with regards to PV topics/involvement (e.g. safety reporting requirements, PV clauses in contracts, reconciliations, vendor selection) including set-up of electronic AE/ADR reporting

•           Oversee PV operations activities with concerned Contract Research Organizations (CROs), including reconciliation activities; supervising PV agreements with CROs

•           Ensure data related to each process under the area of competency of PM PV OPS team are properly filled out in the PSMF

•           Open deviations related to the activities under the role and contribute to the investigation(s) and CAPA Plan implementation

•           For all GVP audits and inspections, serve as the expert for activities under the role, Pre-work in preparation for the audit/inspection, Direct interviews with auditors/inspectors, as required, and Follow-up on any subsequent actions and CAPAs

•           Actively participate in process improvement activities within the GRAPS department

•           Maintain compliance with relevant regulations, policies and procedures

You will need to have

• Degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or a related scientific discipline.
• Solid experience in Pharmacovigilance Operations within a pharmaceutical, biotechnology, or healthcare environment.
• Strong knowledge of global pharmacovigilance regulations, GVP requirements, and post-marketing safety processes.
• Experience managing safety data collection activities and ensuring data quality, compliance, and timely reporting.
• Demonstrated ability to work effectively with cross-functional and international stakeholders.
• Excellent communication, influencing, and stakeholder engagement skills.
• Experience working with external vendors and service providers, ensuring effective oversight and compliance.
• Strong analytical, problem-solving, and continuous improvement mindset.
• Experience supporting audits, inspections, or compliance-related activities in a regulated environment.
• Professional proficiency in English, both written and spoken.

We would prefer for you to have

• Advanced knowledge of post-marketing safety data collection channels, mainly of ODCS and literature monitoring.
• Experience with medical device and combination product vigilance activities.
• Experience managing pharmacovigilance activities in a global and matrix organization.
• Knowledge of safety agreements, vendor governance, and CRO oversight.
• Experience with pharmacovigilance quality systems, deviations, CAPAs, and inspection readiness programs.
• Familiarity with Pharmacovigilance Service Providers and outsourced operating models.
• Experience delivering training and driving process implementation across global teams.
• Knowledge of safety databases, digital PV solutions, and emerging technologies supporting PV operations.
• Project management or change management experience in a regulated environment.

Location

The position is based at our headquarters in Parma and offers a flexible hybrid working arrangements.

Compensation range