AD, Medical Assessment and Signal Detection Lead, GPS Medical Science - ID:2006b
$220–$235,000 year
HybridPalo Alto, California, United States or Princeton, New Jersey, United States
Job Summary
Conduct medical review, assessment, and approval of Individual Case Safety Reports (ICSRs) from clinical trials and post-marketing. Perform signal detection activities by analyzing single case reports, aggregate safety reports, and relevant literature to identify trends and concerns regarding Ascendis products. Support Program Safety Leads with assigned tasks, liaise with Medical Monitors for adverse event reports, and provide pharmacovigilance expertise to CRO or vendor staff. Provide medical input for expedited and aggregate safety reports including SUSAR, PSUR, and DSUR, and lead responses to regulatory authority safety queries. Monitor industry best practices and recommend updates to departmental policies and SOPs while ensuring compliance during regulatory inspections. Requires 5+ years in pharma with expertise in safety surveillance and FDA/EMA regulations; hybrid role based in Palo Alto, CA with up to 20% travel.
Required Qualifications
- 5+ years' experience in Pharma
- thorough understanding of PV processes
- Expertise in safety surveillance, signal detection, regulatory compliance, and benefit-risk assessment
- Working knowledge of FDA, EMA PV regulations, ICH Guidelines, and other applicable regulatory guidance documents
- Working knowledge of global safety regulations
- Ability to travel up to 20% of the time domestically and internationally
- This is a hybrid role operating preferably out of Palo Alto, CA
- Candidates to apply residing near our Princeton, NJ office
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