Are you looking to make an impact with your innovation? We are working with a well-established pharmaceutical company to search for a new Safety Director!

Proclinical is seeking an Associate Safety Director to provide safety science and pharmacovigilance expertise across the drug development lifecycle. You will play a vital role in ensuring the safety of assigned products, contributing to regulatory submissions, risk management, and signal detection. This position offers a hybrid work model following an initial training period.

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:

• Develop and maintain a deep understanding of the safety profile of assigned products or therapy areas.
• Oversee individual and aggregate case reporting activities, including medical review and preparation of reports such as DSURs and PBRERs.
• Conduct signal detection and management, including safety assessments and responses to regulatory authority requests.
• Contribute to the development and execution of product safety strategies.
• Manage risk communication and documentation, including CCDS, labeling, IB, and RMP preparation.
• Review clinical protocols, study reports, and other related documents to ensure alignment with safety strategies.
• Support regulatory submissions, including INDs, NDAs, MAAs, and variations.
• Prepare and maintain safety sections of the Company Core Data Sheet and Reference Safety Information.
• Participate in internal and external safety review committees and governance meetings.
• Collaborate with cross-functional teams and vendors to ensure safety science deliverables are met.
• Apply statistical methods to analyze and interpret complex data, presenting findings clearly.
• Drive process improvements and contribute to non-molecule projects or due diligence evaluations as needed.

Key Skills and Requirements:

• Qualified healthcare professional or life sciences graduate; advanced qualifications (e.g., PhD, MSc, PharmD) are advantageous.
• Experience in drug development, with a focus on drug safety/pharmacovigilance.
• Proficiency in safety database tools and Microsoft Office applications (Excel, Word, PowerPoint).
• Strong understanding of GxP and clinical trial processes.
• Excellent written and verbal communication skills in English.
• Ability to work effectively in global, cross-functional teams.
• Strong analytical and presentation skills, with the ability to synthesize and communicate complex data.
  

If you are having difficulty in applying or if you have any questions, please contact Joshua Bye at j.bye@proclinical.com.

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.