Senior Global Safety Specialist

Category: Regulatory Affairs
Country/Region: DK
Location: Odense, DK, 5260 Søborg, DK, 2860

Ensuring the safety of post-marketed medicinal products within a dynamic team environment.
Do you enjoy flexibility in your work life and value the possibility of hybrid work? Do you have great competencies in signal management, aggregate reporting, and compliance tracking within the Global Safety Surveillance team? And do you thrive in a collaborative and fast-paced environment? Then this might just be the perfect role for you.

About the job
As a Senior Specialist in the Global Safety Surveillance team, you will play a crucial role in ensuring the safety of post-marketed medicinal products. Our team consists of dedicated professionals with extensive knowledge in pharmacovigilance.

Your main responsibilities will include:

• Signal Management activities
• Aggregate Reporting activities
• Interacting with competent authorities
• Extraction and analysis of pharmacovigilance data
• Overseeing vendor literature monitoring
• Strong cooperation with other departments, stakeholders and affiliates
• Promoting, maintaining, and improving compliance with the legal requirements in the EU
• Leading tasks/projects within the team and ensuring that deadlines are met
• Contribute to the ongoing globalization

This role requires flexibility to lead some tasks and act as a backup for others, depending on your interests and experience. An aptitude for IT systems and digital solutions within pharmacovigilance is highly advantageous.
We expect you to take a high professional responsibility in the daily work and that you are able to train other specialists. It is highly expected, that you dare to take the lead in decisions – and that you can manage a coordinating role in different projects. A front person with great expertise.

Who are you?
The ideal candidate is a Pharmacist, Cand. Scient., or holds a similar qualification, with experience in Pharmacovigilance or other compliance-related fields within the pharmaceutical industry.

You work in a structured manner and are capable of joggling different tasks and deadlines. It is important that you are a proactive team player, who has the capability of working independently, as both scenarios are important in the daily work.

Additionally, we expect you to:

• Have a commercial mindset
• Communicate professionally in English, both written and spoken
• Be in possession of great analytical and coordinating skills as well as seeing both the details and the bigger picture

Who are we?
The pharmacovigilance team has grown significantly due to recent acquisitions. Currently, the Global Safety team consists of 10 engaged specialists, with 3 located in our Søborg office and the rest in Odense.

We value a casual, positive, and humoristic social tone. We make room for both laughter and seriousness in an exciting and dynamic work environment. We emphasize responsibility for individual areas while supporting each other professionally and personally.

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. In 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 in 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 where 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 13 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 operate within seven different business areas: Over the Counter (OTC), Consumer Healthcare, Generics, Promotional Rx, Unlicensed Medicines, Parallel Import and Clinical Trials Supplies (CTS). Further, we focus heavily on new business opportunities and synergistic M&A to expand our offerings

We offer
At Orifarm, we know our growth comes from the growth of our employees. We are an ambitious organization with an entrepreneurial culture, and we celebrate can-do attitudes, smarts and hearts. Our secret to success? Valuing how different skillsets join forces to make our journey happen. Whether you play a direct or an indirect part of fulfilling our purpose, you get to contribute and use your skills, personal as well as professional. Indeed, at Orifarm your personal growth journey is shaped only by your contribution towards making healthy days for as many as possible.

We regard our feedback culture as a fundamental element in the individual employee’s opportunities for learning and development. And when we have good results, every employee, including student workers, are a part of our bonus scheme.

Job Location
You can choose to be affiliated with either our office in 5260 Odense or 2860 Søborg. Remote work options are available. All applicants based in the EU are invited to apply as well.

Need further information?
If you need further information about the job, please contact either:

• Sarah Rohde Friis, Department Manager, Global Safety Surveillance, at [email protected]
• Maria Harritsø Wolff, Director, Global Safety & EU/UK QPPV, at [email protected]

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/

Application deadline
Please apply as soon as possible, as interviews will be conducted on a rolling basis. The final deadline for applications is July 28, 2024.

Submit your resume (CV) with a short description of yourself and your motivation for applying.