Global Safety Associate 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

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Data Handling, Case Handling, Regulatory Compliance, Communication Skills, Organizational Skills, Attention to Detail, Teamwork, Microsoft Office, Safety Databases, Documentation Management, Quality Control, Data Analysis, Literature Screening, Training, Continuous Improvement

Industry

Pharmaceutical Manufacturing

Description

About the job The Global Safety Associate supports the 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 assisting in the maintenance of the Pharmacovigilance System, supporting data collection and analysis, and helping identify trends and potential safety signals under guidance from senior team members. Main tasks and responsibilities: Case Handling and Reporting Support collection, entry, and processing of adverse event data in compliance with regulatory and internal requirements Assist in the preparation and submission of individual case safety reports (ICSRs) Conduct and document ICSR reconciliations with partners and vendors Maintain accurate and timely safety records in the safety database Data Support Contribute to data quality control and verification activities Pharmacovigilance System and Process Support Support maintenance of PV processes, procedures, and documentation Assist in the maintenance and tracking of Pharmacovigilance Agreements (PVAs) Support literature screening, data reconciliation, and quality checks Contribute to audit and inspection readiness by maintaining proper documentation Perform daily administrative tasks that support PV operations and documentation control Regulatory Compliance Assist in maintaining the product library by updating safety-relevant information as directed Support tracking and documentation of regulatory intelligence related to pharmacovigilance Help implement procedural updates following regulatory changes Cross-functional Collaboration Support communication and coordination between global and local PV teams and other internal functions Provide timely responses to safety-related requests and follow-up Continuous Improvement and Learning Contribute ideas for improving PV processes and workflows Participate in training to build pharmacovigilance knowledge and technical competence Who are you? Ideal candidate would have: Min. bachelors in Life Sciences, Pharmacy, Nursing, or another relevant scientific discipline Could be newly educated and eager to learn the required qualifications and competences 0–2 years of experience in pharmacovigilance or another regulated area (e.g. clinical research, medical information, or quality assurance) Basic understanding of pharmacovigilance principles, case handling, and regulatory requirements is an advantage Familiarity with safety databases or other data management systems is an advantage Experience with ICSR reconciliation, documentation management, or PV administrative support is an advantage Strong attention to detail and accuracy in data handling Willingness to learn and develop within a global pharmacovigilance environment Strong organizational skills and ability to follow structured procedures Team-oriented mindset with good communication skills Proficiency in Microsoft Office tools; experience with safety databases is an advantage. Fluent in written and spoken English Strong written and verbal communication skills Who are we? The Global Safety Associate 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 Associate supports the monitoring and reporting of the safety profile of company products in compliance with pharmacovigilance regulations. This role involves case handling, data support, and maintaining the Pharmacovigilance System.