Are you passionate about upholding high standards of quality in the pharmaceutical industry? Do you thrive in a dynamic, agile environment where your expertise directly contributes to making essential medications accessible to patients worldwide? We are seeking an experienced Pharmacovigilance and Regulatory officer to join our team in Lancy, Geneva. This role is crucial in ensuring that our products meet rigorous safety, quality and regulatory standards as we expand both in Switzerland and globally.
About Us:
Leman SKL Pharmaceuticals is a private and independent Swiss pharmaceutical company headquartered in Switzerland. With strategically located subsidiaries across Europe, Mexico, and Hong Kong, we operate on a global scale, enhancing our international presence. As a fast-growing company, we pride ourselves on agility, pragmatism, and dedication to providing valuable products to healthcare professionals and patients. We foster a collaborative, growth-oriented environment where our team members can advance their expertise through hands-on experience and continuous training.
Your Role:
As a Pharmacovigilance and Regulatory Officer, you will play a pivotal role in ensuring that our pharmaceutical products comply with stringent safety, quality, and regulatory standards. Reporting to the Regulatory Manager, you will oversee critical pharmacovigilance activities and ensure the company’s products adhere to both national and international regulations. Your work will help us maintain a high standard of patient safety and product quality as we continue to expand globally. Your key responsibilities will include:
- Pharmacovigilance management :
- Implement and manage the pharmacovigilance system to ensure compliance with applicable regulations, in direct connections with the Company’s global and local PV-Partners.
- Handle the collection, processing, and reporting of adverse drug reactions (ADRs) and ensure timely submissions to regulatory authorities.
- Monitor the safety profile of products through signal detection and risk management.
- Collaborate with healthcare professionals and regulatory bodies to address safety concerns.
- Regulatory compliance :
- Prepare and submit regulatory documentation for product registrations, renewals, variations, and compliance with health authorities (e.g., Swissmedic).
- Monitor changes in regulations and update internal processes and documentation accordingly.
Your Profile:
- A minimum of 5 years of experience in pharmacovigilance within the pharmaceutical industry with drugs.
- Background as a Pharmacist, Chemist, or similar, with in-depth knowledge of GMP regulations and Swiss drug registration requirements.
- Ability to work independently on multiple projects with a high level of attention to detail.
- Language proficiency in French and English; German is a plus.
What We Offer:
- Career development: Opportunity to take on Pharmacovigilance responsibilities and access in-house and external training programs.
- Dynamic work environment: Join a vibrant, growth-focused team in a company that values agility, collaboration, and excellence.
- Benefits: Enjoy 30 days of paid leave per year and the option for partial home office work to support a healthy work-life balance.
Why Join Us Now?
Our company is expanding rapidly, with several new medications set to launch in Switzerland and plans to grow internationally. As Pharmacovigilance and Regulatory Officer, you will play a key role in ensuring the success of our growth while making a real impact on healthcare. If you’re ready to bring your pharmacovigilance expertise to a company that values growth and impact, we would love to hear from you. Apply now to be part of our mission!