Associate Director/ Senior Manager / Manager Global Patient Safety Scientist

Global Patient Safety Scientist

The global patient safety scientist will play a key scientific role in safety strategies for assigned products in clinical development and post marketing. This will include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.

Responsibilities:

• Perform signal detection activities for assigned products in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author the safety evaluation report.
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other stakeholder queries etc
• Prepare and deliver presentations at SMT meetings; participate in clinical study team meetings as appropriate for assigned products.
• Participate in other risk management activities as appropriate for assigned compounds.
• May represent GPS for assigned compounds on cross-functional teams, including Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents.

Requirements:

• Master's, PhD, or PharmD
• Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 5 years of risk management or relevant clinical experience in pharmaceutical/biotech industry or health authority.
• 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 utilize GPS safety system database for purposes of medical case review and simple queries.
• Ability to effectively communicate (verbal and written) safety findings.