Lambda Therapeutic Research looking for Aggregate Report Writing professionals
Aggregate report writing refers to the process of compiling and summarizing safety information from multiple sources into a single report. This type of report is typically used in the pharmaceutical industry to monitor and evaluate the safety of a drug or medical device over time.
Aggregate reports are typically required by regulatory agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and are used to assess the overall safety profile of a product. These reports are generated on a regular basis, such as annually or semi-annually, and may include information from a variety of sources including clinical trials, post-marketing surveillance studies, and spontaneous reporting of adverse events.
The process of aggregate report writing typically involves the following steps:
- Identification of relevant data sources: This includes identifying all relevant clinical trials, post-marketing surveillance studies, and spontaneous reports that will be included in the report.
- Data extraction and management: Data is extracted from the identified sources and is organized into a format that can be easily analyzed.
- Data analysis: This includes evaluating the safety data and identifying any potential safety concerns.
- Report preparation: The report is written, including an overview of the product, a summary of the data, any identified safety concerns, and conclusions.
- Review and submission: The report is reviewed by the relevant parties and is then submitted to the regulatory agency.
Overall, aggregate report writing is an important process that helps pharmaceutical companies and regulatory agencies ensure the safety of drugs and medical devices by providing an overall view of the safety profile of a product over time.
job Description;
looking for candidates having 3 to 5 years of experience in preparation/review of full PSUR (PBRER), PADER, RMP, DSUR, and ACOS / AdCO.
Candidate should have skills for critical safety analysis, scientific review, and data presentation followed by effective medical writing.
Candidate should have an experience in the preparation of key safety messages and educational materials for additional risk minimization measures (ARMM).
Candidate should be aware of the process for ARMM implementation and its effectiveness.
A candidate with prior experience in Case Processing and a thorough understanding of ICSR Management and Signal Management is preferred.
Candidate should have a basic understanding of Pharmacovigilance guidelines for the regulated and semi-regulated market.
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aggregate report writers job openings in lambda research ahmedabad