The Associate Director, Safety Scientist in Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases, under the guidance of the safety lead.
This will include review, analysis and interpretation of safety data (including aggregate data) to generate appropriate safety messaging and benefit-risk assessments.
A typical day might include the following :
Complete signal detection activities in line with approved safety surveillance plan.
Perform signal evaluation for any identified signals and author the safety evaluation reports.
Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries.
Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds.
Participate in other risk management activities as appropriate for assigned compounds.
We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron.
Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents.
This role might be for you if can :
Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
Ability to work with a safety system database.
Ability to prioritize and multitask to meet deliverables.
Ability to effectively communicate (verbal and written) safety findings.
To be considered for this opportunity, you must have the following :
Master's, PhD, or PharmD (preferred).
10+ years of relevant safety related experience in the pharmaceutical / biotech industry or health authority.
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