Be the expert behind safer medicines-leading signal detection and global safety strategy.
Proclinical is seeking a Senior Pharmacovigilance Specialist to support safety management activities for pharmaceutical products in the cardiovascular space. In this role, you will lead critical pharmacovigilance processes, including safety signal management, aggregate report preparation, and regulatory responses. You will also act as a subject matter expert on global safety regulations and guidelines, ensuring compliance and maintaining product integrity throughout clinical trials and post-marketing phases.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Lead safety signal management processes, including detection, tracking, documentation, and evaluation of safety data.
- Synthesize data from multiple sources and author signal evaluation reports.
- Manage literature reviews to identify relevant safety information.
- Oversee the preparation, review, and finalization of aggregate safety reports, such as PSURs, DSURs, Risk Management Plans (RMPs), and other related documents.
- Respond to safety-related inquiries from regulatory authorities.
- Collaborate with cross-functional teams, including Safety, Clinical Development, Medical Affairs, and Regulatory, to support investigational programs and clinical trial activities.
- Provide clinical judgment and analysis for case information and safety data.
- Facilitate Safety Signaling Team meetings and ensure alignment on safety strategies.
Key Skills and Requirements:
- Strong ability to interpret, analyze, and present scientific and medical data clearly in both verbal and written formats.
- Expertise in pharmacovigilance processes, including safety signal management, aggregate report authoring, and regulatory compliance.
- Solid understanding of global clinical trial and post-marketing safety regulations.
- Proficiency in data processing tools such as Excel, PowerPoint, and Word, as well as familiarity with safety database systems.
- Demonstrated leadership and collaboration skills within cross-functional teams.
- Strong organizational abilities, with the capacity to prioritize tasks independently.
- Educational background in biological or natural sciences, health disciplines, or an advanced degree (e.g., PhD, MPH, NP, PharmD).
- Experience in pharmacovigilance, particularly in aggregate safety reporting and signal management.
If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.
Apply Now:
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy
