Head of Safety Data Management and Regulatory Reporting, Global Pharmacovigilance and Patient Safety

Your role Would you like to lead global pharmacovigilance operations and strengthen patient safety through digital innovation? At Orion, you will lead the team responsible for safety data management and regulatory reporting, overseeing post-approval and clinical study safety reporting processes worldwide. As part of Orion’s digital transformation and growth, you will develop more streamlined, harmonized ways of working and turn new technologies into practical improvements. In collaboration with global and local pharmacovigilance teams and cross-functional partners, you will balance innovation with regulatory compliance and business continuity. You will report to the Vice President, Global Pharmacovigilance and Patient Safety / QPPV. This is a new permanent and full-time position which is based at our Espoo office in Finland and offers the flexibility of Orion’s hybrid working model. Responsibilities

• Lead the safety data management and regulatory reporting team within the

Global Pharmacovigilance and Patient Safety unit at Orion’s headquarters.

• Oversee and develop global post-approval and clinical study safety reporting

processes.

• Ensure that ICSR and SAE management and regulatory reporting meet

international regulatory requirements and standards.

• Drive continuous improvement and digital transformation of pharmacovigilance

processes, with a focus on:

• Introducing AI and process automation in safety data management and

reporting, supported by guidance and policies developed with internal stakeholders to ensure controlled adoption.

• Maintaining business continuity in ICSR and SAE management and reporting.
• Implementing lean, harmonized data management practices and reporting

systems with Orion affiliates and service providers worldwide.

• Developing pharmacovigilance dashboards, data visualization and analytics

capabilities.

• Working closely with IT experts, data system owner and administrator,

system vendors and service providers. What you can expect from us We offer a leadership role with meaningful responsibility and the opportunity to influence how global pharmacovigilance operates at Orion. Your expertise and ideas will help shape our processes and the way we use digital solutions to support patient safety. You will join an international, collaborative environment where experienced colleagues share knowledge and support one another. The role offers opportunities to deepen your expertise in pharmacovigilance operations management and develop your capabilities in digital transformation and change management. At Orion, our work creates well-being for customers, patients and society. Friendliness, respect, mutual appreciation and diversity are at the heart of our culture, creating a safe working environment where you can strive for excellence. We offer diverse career paths and development opportunities as we create innovative solutions that improve quality of life. Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/. What are we looking for? We are looking for an experienced pharmacovigilance professional who combines strong technical expertise with inspiring leadership and a collaborative, solution-oriented approach. Expertise

• A suitable academic background, such as an M.Sc. or Ph.D. in Pharmacy, Life

Sciences or a related field

• Extensive experience in pharmacovigilance operations, typically around 10

years

• Strong knowledge of international pharmaceutical legislation, guidance and

regulatory procedures, particularly in pharmacovigilance, clinical trial safety reporting and data management Leadership and impact

• Demonstrated leadership skills and a track record of delivering against

performance and project targets

• Experience leading and developing complex, international cross-functional

processes and operations, including change management, continuous improvement and digital transformation Ways of working

• A collaborative and proactive approach, with sound decision-making,

analytical and organizational skills

• Excellent communication and interpersonal skills, with the ability to build

strong relationships and work effectively across functions and cultures

• Fluency in English, which is the working language. Basic spoken Finnish is

considered as an advantage in this position How to apply Interested? Please submit your application by November 29th, 2026. We review applications throughout the application period and may invite candidates to interview before the closing date, so we encourage you to apply early. For more information, please contact Jukka Pesonen, Vice President, Global Pharmacovigilance and Patient Safety, tel. +358 50 966 4937. The best times to call (Finnish time) are November 16th, 8:00–9:30, November 18th 9:00-10.00 and November 20th at 12:00-13:30. #LI-ORION Approved medical examination which also includes drug testing is required prior to the employment. We will also carry out a security clearance prior to the employment for the selected person. Your new team Quality management (QM) is responsible for ensuring the quality of materials, products and operations, as well as maintaining and developing the quality system and monitoring the regulatory environment. Pharmacovigilance and Patient Safety unit is responsible for the global pharmacovigilance system of Orion Corporation and for the continuous safety surveillance, regulatory reporting and safety risk management activities of human and veterinary medicinal and non-medicinal products. The QM function consists of about 400 experts who work in Quality Control, Quality Assurance, Quality System, Method Development and the Pharmacovigilance & Drug safety unit. We are located in Espoo, Turku, Salo and Kuopio plants, in addition to the Quality Assurance team in India reporting dotted-line to QM. Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years. We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future. Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more. We offer careers with a clear purpose: empowering people to live their lives to the fullest. About Orion [https://www.orionpharma.com/about-orion/]