Global Safety Specialist at Orifarm A/S

Warsaw, Masovian Voivodeship, Poland -

Full Time

Start Date

Immediate

Expiry Date

31 Jan, 26

Salary

0.0

Posted On

02 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Data Analysis, Signal Detection, Regulatory Compliance, Collaboration, Communication, Attention to Detail, Proactive Mindset, Safety Databases, ICSR Reconciliation, Pharmacovigilance Agreements, English Fluency, Cross-Functional Teamwork, Risk Management, Documentation Control

Industry

Pharmaceutical Manufacturing

Description

Orifarm is looking for a Global Safety Specialist with a passion for patient safety and a talent for translating complex data into clear safety insights. In this role, you’ll be a key player in driving pharmacovigilance activities and ensuring our products meet the highest global safety standards. About the job The Global Safety Specialist ensures continuous monitoring, evaluation, and reporting of the safety profile of company products in compliance with global pharmacovigilance regulations and internal procedures. The role contributes to safeguarding patient safety by maintaining and enhancing an effective Pharmacovigilance System, performing data analysis to identify trends and signals, and providing insights that support proactive risk management and safety-related decision-making. Main tasks and responsibilities include: Case Management and Reporting : • Ensuring timely and accurate processing, evaluation, and reporting of individual case safety reports (ICSRs) in accordance with regulatory requirements and internal procedures• Overseeing quality and compliance in case handling and data entry and reconciliation of ICSRs with partners and vendors Data Analysis and Signal Detection:• Assisting in data analysis to identify safety trends, potential signals, and areas requiring further evaluation • Contributing to signal detection and risk evaluation to identify potential safety issues Pharmacovigilance System and Process Maintenance:• Supporting the maintenance and continuous improvement of the Pharmacovigilance System• Overseeing the maintenance and tracking of Pharmacovigilance Agreements (PVAs) to ensure compliance with regulatory and contractual requirements• Participating in the maintenance of the product library and ensure accuracy of safety-relevant product information• Performing daily administrative tasks that support PV operations and documentation control Regulatory Compliance: • Ensuring all pharmacovigilance activities comply with global regulatory requirements• Monitoring and assessing regulatory intelligence related to pharmacovigilance to ensure alignment with evolving global requirements• Supporting implementation of regulatory changes within internal PV procedures and systems and adapting processes accordingly Collaboration and Communication:• Collaborating with cross-functional teams• Communicating findings and recommendations to stakeholders• Providing PV input to projects, procedures, and cross-functional initiatives Continuous Improvement:• Contributing to the improvement of pharmacovigilance processes and systems and documentation updates• Contributing to knowledge sharing and best practice development across the global safety function • Participating in training and development activities. Who are you? Ideal candidate would have: Minimum of 3 year of experience in pharmacovigilance Min. master’s degree in pharmacy, medicine, life Sciences, or a related field Understanding of global pharmacovigilance regulations and guidelines Familiarity with pharmacovigilance databases Experience in maintaining Pharmacovigilance Agreements (PVAs) Experience in erforming ICSR reconciliations Knowledge of data analysis tools Proactive and optimizing mindset Ability to interpret data sets and derive insights High attention to detail and commitment to accuracy and compliance Proficiency with safety databases and standard PV tools (e.g. Veeva, Excel) Fluent in written and spoken English Strong written and verbal communication and collaboration skills across functions and geographies Ability to prioritize and manage multiple tasks in a dynamic, deadline-driven environment Ability to support decision-making based on data and evidence Ability to work effectively within cross-functional teams Who are we? The Global Safety Specialist will be a crucial member of our team, dedicated to maintaining the highest standards of drug safety and making informed decisions to protect patient health. What we offer: Fulltime employment contract Life insurance Private medical care Sports card PPK Hybrid work model Flexible working hours Annual bonus Job Location Our Warsaw office, located in the prestigious Gdański Business Center at Inflancka 4, is designed to foster collaboration and innovation, ensuring an excellent working environment for our employees. Application deadline Applications will be assessed in November until the position has been filled. Why should you work for Orifarm? At Orifarm, we know that our growth comes from the development of our employees. We are an ambitious organization with an entrepreneurial culture celebrating can-do attitudes, smarts, and hearts. Our secret to success? Valuing how different skill sets join forces to make our journey happen. You will experience a work environment characterized by flexibility and a strong commitment to work-life balance, understanding that the best results come from satisfied and well-supported employees. Our international setting offers great opportunities for growth and career advancement. We also prioritize social events and gatherings to ensure that our employees feel connected and engaged with each other. We regard our feedback culture as a fundamental element in the individual employee's opportunities for learning and development. When we have good results, every employee, including student workers, is part of our bonus scheme. About Orifarm Everyone should have access to modern medicine. High costs or lack of access to pharmaceuticals should never impact our possibility to receive treatment or relief and live a healthy life. At Orifarm, we aim to bring healthy days by making modern healthcare a better deal for the people and the societies we serve. Working towards our vision, we create access to affordable, high-quality pharmaceuticals and healthcare products by challenging markets and always seeking new opportunities. With our core values paving the way, we always act responsibly and constantly with our customers at the center of our attention. And everything we do is driven by our sole purpose: For as many as possible, as healthy a day as possible. Our history goes back to 1994 when Orifarm was founded in Denmark by Hans and Birgitte Bøgh-Sørensen. Since then, Orifarm has grown from a small nine-person company into an international company operating globally in 15 countries. Today, Orifarm is Europe's largest parallel importer of pharmaceuticals and Denmark's largest supplier of pharmaceuticals, with more than 2,200 employees. We encourage everyone to apply At Orifarm, we welcome people from all backgrounds, recognizing that the best outcomes come from a diverse and inclusive work environment. Our commitment is to create an environment where different perspectives and skills drive innovation and contribute to a sustainable future. By creating such an environment, we are confident that we can achieve better results together. We are often looking for new employees to help us grow and therefore, we may have other interesting opportunities for you. Follow us on LinkedIn to receive updates on our business activities and job opportunities: https://www.linkedin.com/feed/.

Responsibilities

The Global Safety Specialist is responsible for monitoring, evaluating, and reporting the safety profile of company products in compliance with pharmacovigilance regulations. This role involves data analysis to identify trends and signals, contributing to proactive risk management and safety-related decision-making.