GRAPS Safety Operations, Clinical Trials Manager (Pharmacovigilance)

TL;DR

GRAPS Safety Operations, Clinical Trials Manager (Pharmacovigilance): Managing pharmacovigilance operations within interventional clinical trials to ensure regulatory compliance and data quality with an accent on safety data collection, vendor oversight, and process maintenance. Focus on implementing PV requirements into corporate procedures, overseeing CROs, and ensuring high-quality safety data delivery to regulatory agencies.

Location: Must be based in or be able to relocate to Parma, Italy (Flexible hybrid arrangement)

Salary: From €46,000 + annual bonus

Company

hirify.global is an international research-focused biopharmaceutical group and certified B Corp operating in over 30 countries.

What you will do

• Carry out pharmacovigilance (PV) operations for interventional clinical trials to meet evolving PV legislation.
• Ensure the strategic collection, assessment, and timely delivery of high-quality safety data to agencies.
• Act as a subject matter expert for CT PV OPS processes, managing requirements, training, and vendor oversight.
• Oversee PV operations activities performed by Contract Research Organizations (CROs) and other service providers.
• Review PV-relevant sections of clinical trial documents and maintain the Pharmacovigilance System Master File (PSMF).
• Manage PV OPS activities through Post-Integration phases for R&D assets and support GVP/GCP audits.

Requirements

• Master's degree in science, medicine, biology, pharmacy, or related fields.
• Minimum 4 years of experience in R&D within the Pharmaceutical or Biotechnology industry.
• At least 3 years of specific experience in Pharmacovigilance or Clinical Research.
• Fluent English proficiency.
• Ability to work in Parma, Italy.
• Strong communication, problem-solving, and analytical skills.

Nice to have

• Knowledge of global pharmacovigilance requirements.
• Awareness of GCP (Good Clinical Practice) requirements.
• Familiarity with the MedDRA coding dictionary and its principles.

Culture & Benefits

• Comprehensive healthcare programs and private medical insurance.
• Competitive salary package with performance bonuses.
• Robust relocation support and tax assistance for foreign colleagues.
• Work-life balance initiatives and flexible working arrangements.
• Pension plan and wellbeing programs.
• Inclusive environment within a certified Benefit Corporation (B Corp).