PV Operations Manager, Clinical Trials — Hybrid

Chiesi Group; Parma; Ibrido; EUR 46.000 - 58.000; Tempo pieno

Vantaggi offerti da questo lavoro

Pension

Private medical insurance

Wellbeing programme

Flexible benefits programme

Relocation support

Remote work options

Descrizione del lavoro

Chiesi Group, headquartered in Parma, is seeking a Pharmacovigilance professional to lead PV OPS activities for interventional trials in a diverse, international setting. You will ensure PV requirements are embedded in processes, train staff, and collaborate with CROs and affiliates to deliver high-quality safety data.

The role requires a Master’s in science or related field, 4+ years in R&D with PV/Clinical Research experience, and strong communication and analytical skills.

Competenze

• Master degree in science, medicine, biology, pharmacy or related fields.
• Minimum 4 years of experience in R&D within Pharmaceutical and/or Biotechnology industry, with at least 3 years in Pharmacovigilance or Clinical Research.
• Willingness to operate in a diverse, international environment.
• Excellent communication and interpersonal skills.
• Ability to work with initiative and autonomy, demonstrating determination in achieving goals and tackling daily challenges
• Problem solving and decision making skills
• Planning and analytical skills

Mansioni

• Carry out pharmacovigilance (PV) operations (OPS) activities in interventional clinical trials (CT) sponsored by GCD or GRD functions by maintaining up-to-date processes for safety-related aspects of interventional clinical trials, to meet current and evolving PV legislation
• Support the GRAPS Safety Operations CT Head in ensuring that all current PV requirements for interventional clinical trials are effectively incorporated into Chiesi processes and documented in procedures
• Ensure strategic collection, assessment and delivery of high-quality clinical trial safety data in a timely manner, ensuring that it is correct, consistent, compliant and delivered to agencies
• Actively engage CT customers, affiliates and other stakeholders
• Participate in interdepartmental meetings inside and outside R&D
• Act as owner (i.e. subject matter expert) for specific processes under the area of competency of CT PV OPS Unit, responsible for implementing requirements, training, procedure maintenance, vendor oversight
• 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 clinical trials with regards to PV topics/involvement
• Oversee PV operations activities with concerned Contract Research Organizations (CROs)
• Ensure data related to each process under the area of competency of CT 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
• Manage PV OPS activities throughout Post-Integration phases, for R&D assets
• For all GVP and GCP audits and inspections, serve as the expert for activities under the role
• Actively participate in process improvement activities within the GRAPS department
• Maintain compliance with relevant regulations, policies and procedures

Descrizione del lavoro

Chiesi Group, headquartered in Parma, is seeking a Pharmacovigilance professional to lead PV OPS activities for interventional trials in a diverse, international setting. You will ensure PV requirements are embedded in processes, train staff, and collaborate with CROs and affiliates to deliver high-quality safety data.

The role requires a Master’s in science or related field, 4+ years in R&D with PV/Clinical Research experience, and strong communication and analytical skills.