Senior Global Safety Specialist

Senior Global Safety Specialist

Orifarm is looking for a pharmacovigilance specialist with a sharp analytical mindset and strong analytical skills. As our new Senior Global Safety Specialist, you will take ownership of PBRER preparation, signal detection, and data-driven safety evaluations – all within a dynamic, global environment.

About the job

The Senior Global Safety Specialist will play a pivotal role in ensuring the highest standards of drug safety and efficacy. This position involves the proactive search for new information, independent decision-making based on collected data, and the meticulous writing of Periodic Benefit-Risk Evaluation Reports (PBRERs). The incumbent will also be responsible for performing comprehensive signal detection to identify potential safety issues. This role requires a proactive, analytical, and detail-oriented professional with a strong background in pharmacovigilance and data analysis.

Main tasks and responsibilities:

PBRER Preparation:

• Lead the preparation and writing of Periodic Benefit-Risk Evaluation Reports (PBRERs) in compliance with regulatory requirements.
• Ensure timely submission of PBRERs, incorporating the latest data and risk assessments.

Signal Detection:

• Perform signal detection activities to identify potential safety issues.
• Utilize advanced methodologies and tools to analyze data from various sources.
• Assess the significance of detected signals and escalate potential risks to relevant stakeholders.

Proactive Information Search:

• Continuously search for new information on drug safety and efficacy.
• Stay updated with the latest scientific literature, clinical studies, and regulatory changes.
• Integrate new findings into safety assessments and reports.

Independent Decision-Making:

• Make independent decisions based on collected data and evidence.
• Provide expert recommendations on safety issues and risk management strategies.

Data Analysis:

• Perform in-depth analysis of pharmacovigilance data to identify trends and patterns.
• Use statistical tools and software to derive meaningful insights from large datasets.

Collaboration and Communication:

• Collaborate with cross-functional teams, including Regulatory Affairs, Quality Assurance and Market insights.
• Communicate findings and recommendations effectively to internal and external stakeholders.

Regulatory Compliance:

• Ensure all pharmacovigilance activities comply with global regulatory requirements and guidelines.
• Monitor changes in regulations and adapt processes accordingly.

Continuous Improvement:

• Contribute to the continuous improvement of pharmacovigilance processes and systems.
• Participate in training and development activities to enhance skills and knowledge.

Who are you?

Ideal candidate would have:

• Advanced degree (Master’s or PhD) in Pharmacy, Medicine, Life Sciences, or a related field.
• Minimum of 3 years of experience in pharmacovigilance, specifically at a headquarters level.
• Proficiency in pharmacovigilance databases, signal detection methodologies, and data analysis tools.
• Strong analytical thinking, with the ability to interpret complex data sets and derive actionable insights.
• Excellent written and verbal communication skills, with a proven track record of writing PBRERs and other safety reports.
• Demonstrated ability to make independent decisions based on data and evidence.
• Proactivity in searching for new information and staying updated with the latest industry trends and regulatory changes.
• High level of accuracy and attention to detail in all aspects of work.
• Ability to work effectively within cross-functional teams and collaborate with various stakeholders.
• Comprehensive understanding of global pharmacovigilance regulations and guidelines.

Who are we?

The Senior 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.

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.

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.

What we offer:

• Fulltime employment contract
• Life insurance
• Private medical care
• Sports card
• PPK
• Hybrid work model
• Flexible working hours

Application deadline 

Applications will be assessed from the beginning of August onwards until the position has been filled.

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/. Alternatively, if we do not have any vacant positions that match your interests at this time, we encourage you to submit your resume to our talent pool, from which we continuously select candidates: https://careers.orifarm.com/lp/TalentPool/28c5a1691eef5fd4/.