Role & Responsibilities
Prepare aggregate safety reports including PBRERs, PSURs, Addendum PSURs, ACOs, PADERs and PSUR line listings
Perform quality checks of aggregate safety reports in line with client conventions and regulatory requirements
Conduct signal detection activities including cumulative analyses, issue-based event analyses, SERs and Drug Safety Reports
Review published literature and case listings for safety surveillance
Maintain vigilance over important and designated medical events
Interact with client teams to discuss potential safety signals and emerging issues
Support preparation and maintenance of Risk Management Plans (RMPs)
Perform follow-up with clients to obtain incomplete or missing safety information
Perform medical review of Individual Case Safety Reports (ICSRs)
Perform medical review of narratives for Clinical Study Reports (CSRs)
Provide medical guidance to drug safety scientists on ICSR and CSR narrative processing
Maintain up-to-date knowledge of product safety profiles, labeling documents and SOPs
Ensure compliance with global regulatory reporting timelines and requirements
Maintain accurate safety records in compliance with guidelines and SOPs
Qualification
MBBS or MD (preferably in a clinical branch)
Experience
Pharmacovigilance / drug safety experience preferred
Skills
Strong ability to prepare concise and accurate medical synopses and narratives
Ability to evaluate and interpret safety data independently
Excellent written and spoken English communication skills
Proficiency in MS Word, Excel, PowerPoint and web-based safety applications
Strong typing, transcription accuracy and attention to detail
About the Company
Continuum is a leading contract research organization providing services in Pharmacovigilance, Regulatory, Evidence Evaluation and Technology
The organization employs scientists and physicians to support global safety and regulatory operations
Unlock refined AI insights.