1. Aggregate Report - Medical Reviewer
Apply knowledge and expertise in safety aggregate reports, literature surveillance, signal management activities, and benefit-risk management documents.
Responsibilities:
- Prepare reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, and US Periodic Adverse Drug Experience Reports (PADERs) from aggregate data for products, in accordance with client conventions and requirements.
- Conduct quality checks of aggregate reports.
- Perform signal detection-related analyses and reports including cumulative analyses, issue event analyses, Signal Evaluation Reports/Drug Safety Reports, review of published literature, and case listings.
- Monitor important/designated medical events.
- Interact with client personnel to discuss potential signals and issues detected with products.
- Support preparation and maintenance of Risk Management Plans (RMPs) if required
- Follow up and interact with clients to obtain incomplete/missing information to resolve and clarify issues.
- Conduct medical review of individual case safety reports (ICSRs).
- Conduct medical review of narratives for Clinical Study Reports (CSRs).
- Provide medical advice to drug safety scientists to assist them with processing ICSRs and CSR narratives.
- Author responses to regulatory agency/Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
- Conduct and lead ongoing literature safety surveillance for marketed and investigational products. Assist with identifying ICSRs from literature, evaluating events of special interests, and reviewing aggregate data.
- Maintain an excellent knowledge of the adverse event safety profile of assigned drugs, labeling documents, and client guidelines and Standard Operating Procedures (SOPs).
- Stay informed about global regulatory reporting obligations and organize workload to ensure compliance with internal and regulatory timelines for report submissions.
- Maintain records in compliance with guidelines and SOPs.
Requirements:
- A degree in Medicine (MBBS) or a post-graduation qualification (MD), preferably in a clinical branch
- Minimum 3 years experience in various aggregate report Medical Review activities.
- Experience in Cardiovascular (CVS), Neuroscience (CNS), Oncology, Immunology therapeutic areas and Gene Therapy will be an added advantage. Experience with global pharma sponsor will be preferred.
- Ability to make concise, accurate, and relevant synopses of medical text and data, and to write clear medical text.