Senior Drug Safety Associate
1 month ago
Job Summary:
EverSANA is seeking a highly skilled Senior Drug Safety Associate to join our Pharmacovigilance team. As a Senior Drug Safety Associate, you will be responsible for processing and analyzing safety data from clinical trials and spontaneous post-marketing reports. You will work closely with our PV Management and Project Managers to facilitate and meet client project deadlines. Your attention to detail, teamwork, and initiative will be essential in ensuring the timely reporting of adverse events to regulatory authorities and other stakeholders.
Key Responsibilities:
Process and analyze safety data from clinical trials and spontaneous post-marketing reports
Work closely with PV Management and Project Managers to facilitate and meet client project deadlines
Provide support to other PV Associate staff to efficiently manage workload and ensure timely reporting to regulatory authorities and other stakeholders
Participate in the development of other EverSana-PV and client documents such as aggregate reports, standard operating procedures, and work instructions
Collect Adverse Events (AEs) from all sources, track cases through case processing activities, and coordinate workflow activities to promote accurate reporting and efficient time management
Independently triage AEs to determine reportability, assess expectedness, seriousness, and causality in accordance with regulatory guidelines and product reference safety information
Code adverse events in MedDRA using clinical judgment and medications to WHODRUG
Perform Quality Control checks for completeness, accuracy, and consistency of information in the safety database and on regulatory reporting forms
Create draft narratives of events based on case descriptions provided by reporters, applying basic rules of grammar to improve narrative content
Formulate follow-up queries as needed
Ensure regulatory compliance with timelines for individual expedited case report submissions
Provide assistance and timely delivery of information for aggregate reports, ad hoc report compilations, and other regulatory documents as requested
Interact with clients and other stakeholders for safety data collection, data reconciliation, etc.
Develop expertise on all assigned client products within a therapeutic area
Understand applicable corporate and global regulations, guidelines, SOPs, and writing practices
Lead team members to facilitate efficient case processing
Conduct periodic reconciliation of SAEs between drug safety and clinical trial databases for ongoing clinical studies with little or no supervision
Requirements:
BS degree in a life science discipline (e.g., pharmacy, nursing) is preferred
5 years of relevant experience, which includes 3 years in drug safety
Broad knowledge of domestic and international drug safety regulations, industry practices, and standards
Strong attention to detail, teamwork, and initiative
Strong understanding of drug development, drug safety reporting, and regulatory compliance
Excellent working knowledge of MedDRA and WHODRUG coding dictionaries
Familiarity with FDA and international adverse event reporting regulations per ICH guidelines
Understanding of medical terminology and familiarity with principles of adverse event reporting in the pharmaceutical industry is a plus
Must be quality-oriented and demonstrate consistent attention to detail
Must have the ability to follow established processes and the flexibility to adopt new practices and priorities as required
Must have good planning and organizational skills
Knowledge of relevant software including safety database and Microsoft Office
What We Offer:
EverSana is an Equal Opportunity Employer and offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and detail-oriented individual with a passion for drug safety, we encourage you to apply for this exciting opportunity.
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