Pomezia, IT
Specialist, Pharmacovigilance Operations
Are you passionate about ensuring patient safety through accurate and timely pharmacovigilance practices? Join us as a Specialist, Pharmacovigilance Operations and play a key role in safeguarding global health by managing safety data with precision, compliance, and scientific rigor.
Job Purpose:
The Specialist, Pharmacovigilance Operations is responsible for the collection, processing, and submission of individual case safety reports (ICSRs) in compliance with global regulatory requirements and internal standards. As part of the Global PV Operations team, the role ensures timely and accurate management of safety data, contributing to the company’s commitment to patient safety and regulatory excellence.
Key Responsibilities:
- Collect, triage and manage spontaneous post-marketing adverse event reports from all sources to ensure completeness, legibility, validity and reportability in accordance with applicable timelines and internal procedures.
- Perform data entry, data coding, and quality control of safety information in the company’s safety database, if needed.
- Ensure timely submission of ICSRs to regulatory authorities, Affiliates and Third Parties in accordance with applicable regulatory timelines and Pharmacovigilance Agreements (PVAs).
- Perform queries to validate the case as required according to Regulatory requirements.
- Perform ICSRs periodic reconciliations with Affiliates/Third Parties/CSOs.
- Participate in the drafting, reviewing, and maintenance of SOPs and work instructions relevant to PV Operations.
- Serve as a point of contact for external service providers involved in case processing, providing guidance in daily activities and actively monitoring their performance and compliance.
- Utilize and maintain proficiency in key PV systems, including the global safety database and related tools/platforms used for case processing and reporting.
- Participate as product team member in Signal Detection process, if needed.
- Support the person responsible for the Pharmacovigilance Operations unit with operational activities and daily tasks.
- Support audit and inspection readiness by preparing case processing documentation and performing pre-inspection checks in line with regulatory and internal standards.
Location: Bologna
Requirements:
- Degree in Life Sciences (Pharmacy, Biology, Medicine, or related field).
- Previous experience in pharmacovigilance operations, ideally within the pharmaceutical industry or a CRO.
- Good knowledge of ICSR processing, regulatory requirements (including EMA, MHRA, and ICH guidelines), and pharmacovigilance practices.
- Detail-oriented with a high level of accuracy in data management.
- Proficiency in MS Office (Word, Excel, PowerPoint).
Company:
Alfasigma is a global pharmaceutical company founded over 75 years ago in Italy, where it is headquartered (in Bologna and Milan). The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. It has offices in many countries, including Italy, the US, Spain, Germany, Mexico, and China; production sites in Italy (Pomezia, RM; Alanno, PE; Sermoneta, LT; Trezzano Rosa, MI), Spain (Tortosa, Baix Ebre), and the United States (Shreveport, Louisiana); and R&D labs in Italy (Pomezia and Bergamo). Alfasigma employs approximately 4,000 people dedicated to research, development, production, and distribution of medicinal products, contributing to its mission to provide better health and a better quality of life for patients, caregivers, and healthcare providers. It focuses on three main therapeutic areas: Gastroenterology, Vascular, and Rheumatology. Its portfolio spans from primary care to specialty care, rare disease medications, and consumer health products, including medical foods and nutraceuticals.