Specialist, Pharmacovigilance Operations

Alfasigmas a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

As we continue to grow, we are seeking Pharmacovigilance Specialist.

Scope of role:

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.  This position is located in Bologna.

Your 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.

Who are you:

• 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).

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
 We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.