Associate Director/ Senior Manager / Manager – Global Patient Safety Scientist
Overview
Position Summary
Summary 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 industy 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. Does this sound like you? Apply now! |
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How to Apply
Interested candidates can send their resumes to info@acdlimited.com mentioning "Job Title" in the subject line.
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