Clinical Study Reporting Lead, Global Pharmacovigilance and Patient Safety

Your role

You will lead the global management and reporting of clinical study safety data as part of Orion’s digital transformation and growth journey. This is a senior expert role with no line management responsibilities. Working with a team of experienced experts, you will coordinate and oversee international clinical study safety data management and reporting processes. Alongside day-to-day operations, you will develop and continuously improve these processes in collaboration with internal and external stakeholders and service providers.

This is a new permanent and full-time position which can be based in Espoo, Finland, or UK.

Responsibilities

• Oversee SAE management and SUSAR reporting processes and ensure regulatory compliance

• Develop and coordinate clinical study safety data management and reporting processes

• Develop listings, tables, dashboards and visualizations for clinical safety monitoring and reporting

• Coordinate and develop DSUR-related processes, including scheduling cross-functional tasks, coordinating listings and tables from the safety database, medical writing and supporting Study Physicians

• Maintain study-related content in the Pharmacovigilance System Master File (PSMF) and develop pharmacovigilance tracking tools for studies and organized data collection systems (e.g. ongoing and closed RCT, NIS, MR, PSP, IIS, PASS)

• Develop and oversee study-related processes and agreements with service providers and co-development partners
  

What you can expect from us

Working with colleagues in Global Pharmacovigilance and Patient Safety and our international cross-functional study teams, you will help shape the future of Orion’s global clinical study and safety evaluation operations.

The role offers meaningful responsibility and broad collaboration with global and local teams and other stakeholders. You will turn new ideas and digital capabilities into practical improvements in clinical safety data management processes and ways of working.

You can deepen your expertise in clinical safety operations and broaden your capabilities in international study operations, digital transformation and change management. In a professional, collaborative environment, you will learn from experienced colleagues, share your expertise and make a visible contribution to patient safety at Orion.

At Orion, your work creates true impact and well-being for our customers, patients and society at large. ​ ​Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the 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?

You will thrive in this role if you bring strong clinical study expertise and a collaborative, solution-oriented mindset.

Expertise

• A suitable academic background, such as a B.Sc., M.Sc. or Ph.D. in Pharmacy, Life Sciences, Nursing or a related field
• Extensive experience in pharmacovigilance operations, typically around 10 years

• Strong knowledge of international legislation, guidance and regulatory procedures, particularly clinical trial safety reporting (SAE, SUSARs, DSUR) and data management

Leadership and impact

• A proven track record of meeting performance and project targets

• Experience in leading and developing complex, international cross-functional processes, including change management and continuous improvement

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

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.

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.