Manager, Drug Safety and Pharmacovigilance
Vor 6 Tagen
Contract Type: Permanent
Closing date:
Reference: VN1986
- About us
Join us and be part of a dynamic, future-thinking environment where your contributions can make a positive difference to the lives of patients and consumers.
About the role
Are you ready to take your career to the next level?
You’re an experienced professional in drug safety and pharmacovigilance, with a deep understanding of global pharmacovigilance regulations and medical device standards. You’re familiar with safety databases and adverse event reporting systems, and now you’re looking for a role that offers breadth and variety across a series of unique and different products.
This is a fantastic moment to join us at Vectura Fertin Pharma. We are building a world-class pharmacovigilance function and launching a number of exciting new products. As the Manager, Drug Safety and Pharmacovigilance, you will have the opportunity to shape this new role and develop professionally.
In this role, you’ll be supporting us in doing something that simply hasn’t been done before. You will join a highly experienced team where you will help lead and manage the safety and pharmacovigilance activities for all company products, ensuring compliance with global regulatory requirements and maintaining high standards of patient safety.
Your role will involve collaborating with the brightest and best minds from across our global network, to drive projects from concept to completion.
We don’t work in silos, and our roles are broad, but your key responsibilities will include:
- Monitoring and evaluating the safety profile of all products, ensuring compliance with global pharmacovigilance regulations and adherence to medical device standards.
- Acting as a Safety Lead on assigned projects, analyzing safety data from various sources, identifying trends, and providing risk assessments and recommendations to Safety Management Teams.
- Supporting the preparation and review of regulatory submissions and aggregate safety reports, including PSURs, DSURs, PBRERs, PADERs, etc.
- Collaborating with Clinical Development Teams to ensure safety monitoring and risk management are integrated into clinical development programs.
- Conducting post-marketing surveillance activities, including signal detection, risk assessment, and management of adverse event reports.
- Contributing to pharmacovigilance operations such as oversight of safety vendors, set-up of pharmacovigilance agreements, and maintenance of the PSMF.
- Communicating safety findings and recommendations to internal and external stakeholders through presentations, reports, and direct dialogue.
About you
Ultimately, you are an experienced professional in drug safety and pharmacovigilance, who understands global pharmacovigilance regulations and medical device standards.
With your experience, you can understand development at the ‘systems level’. You know how to handle regulatory compliance, safety databases, adverse event reporting systems, and more. What's more, your passion lies in ensuring patient safety and compliance with regulatory requirements.
We don’t have egos here, we celebrate individual contributions, but collaboration is key to our ongoing success. This is exactly the environment where you thrive.
There is something very special about our people and the work they’re doing. Something that’s hard to capture in words. Based in our beautiful lakeside offices in Lausanne, we’re developing something remarkable.
Opportunities like this are rare. We are privileged to have an amazing team, unparalleled backing from our parent company and, above all, a remarkable vision.
Yes, we face challenges, we face change, we face ambiguity. In life though, every adversity contains the seeds of opportunity.
We’re ready to go. Are you?
**Lausanne, Switzerland**:
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