JMD Technologies Inc.
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The role involves supporting drug safety surveillance and signal evaluation for both marketed and investigational products, ensuring compliance with global regulations.
Responsibilities
Support drug safety surveillance and signal evaluation for marketed and investigational products. Lead aggregate safety report authoring (PSUR, DSUR, PADER). Manage literature reviews, safety data analysis, and ad hoc regulatory responses. Collaborate with Safety Physicians and cross-functional teams on safety governance activities. Maintain compliance with global PV regulations and contribute to process improvement initiatives. Qualifications
5+ years of medical, scientific, or pharma experience, including 3+ years in Drug Safety / PV. Strong background in data analysis, aggregate report writing, and regulatory safety documentation. Excellent collaboration, leadership, and project management skills. Proficiency with MedDRA, Argus, and standard data tools (Excel, PowerPoint, Word). Advanced degree (PharmD, PhD, MD, MPH, RN, NP preferred). Required Skills
Strong background in data analysis. Regulatory safety documentation. Collaboration and leadership skills. Proficiency with MedDRA and Argus. Preferred Qualifications
Advanced degree (PharmD, PhD, MD, MPH, RN, NP preferred). Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices and encourage applications from all qualified individuals.
#J-18808-Ljbffr
Support drug safety surveillance and signal evaluation for marketed and investigational products. Lead aggregate safety report authoring (PSUR, DSUR, PADER). Manage literature reviews, safety data analysis, and ad hoc regulatory responses. Collaborate with Safety Physicians and cross-functional teams on safety governance activities. Maintain compliance with global PV regulations and contribute to process improvement initiatives. Qualifications
5+ years of medical, scientific, or pharma experience, including 3+ years in Drug Safety / PV. Strong background in data analysis, aggregate report writing, and regulatory safety documentation. Excellent collaboration, leadership, and project management skills. Proficiency with MedDRA, Argus, and standard data tools (Excel, PowerPoint, Word). Advanced degree (PharmD, PhD, MD, MPH, RN, NP preferred). Required Skills
Strong background in data analysis. Regulatory safety documentation. Collaboration and leadership skills. Proficiency with MedDRA and Argus. Preferred Qualifications
Advanced degree (PharmD, PhD, MD, MPH, RN, NP preferred). Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices and encourage applications from all qualified individuals.
#J-18808-Ljbffr