Aggregate Report Writer:Responsible for management and timely submission of aggregate reports to achieve 100% global regulatory compliance.Interact with staff at various levels and in various functional areas to resolve any issues that arise during reviews.eCTD PADER submissions and publishing activities (bookmarking, table of contents, hyperlinking).Collection, preparation and finalization of aggregate reports.Provide suggestions and support with respect to modifications in company PV database for its efficiency and making user friendly.Deliver training to new employee and team as per requirement.Assisting QA with document preparation during regulatory audits.

Quality Reviewer:Evaluation and QC of serious adverse event/Post marketing adverse event to ensure accurate and consistent data entry and processing from source documents, with emphasis on timelines and quality.Performing Labeling and Listedness of events with respect to CDS, IB, SPC and USPI. Generating follow up information if required.Determine and assess causality for company comments on case to case basis.Work in conjunction with Case processors to help and support them for accurate and consistent data entry with optimum quality throughout.Work in conjunction with Quality Reviewers and Medical safety physicians to ensure that the reports are accurately evaluated and data based.Assist the medical safety physicians with project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports.Assist the medical safety physicians in monitoring the safety profile of the product.Participate in cross-functional teams on safety matters/special projects related to investigational and marketed drugs.Assists in the training of other Case processors and quality reviewers as necessary.Experience in Case processing and Quality reviewing on different databases as: ARGUS, AERS, PvNET.

Clinical Safety Scientist (CSS):Evaluation and QC of serious adverse event/Post marketing adverse event to ensure accurate and consistent data entry and processing from source documents, with emphasis on timelines and quality.Assess adverse event reports for seriousness, causality and expectedness as per the investigator brochure/Basic prescribing information/US package insert, consulting the Medical Safety Expert whenever needed.Work in conjunction with Clinical safety scientists and Medical safety physicians to ensure that the reports are accurately evaluated and data based.Assist the medical safety physicians with project activities in specific therapeutic areas, compatibly with the timely processing/production of individual case reports and regulatory periodic reports.Assist the medical safety physicians in monitoring the safety profile of the product.Participate in cross-functional teams on safety matters/special projects related to investigational and marketed drugs.

Safety Processing Expert (Trainee Junior Data Analyst):Receive information on adverse events, perform initial checks, search database to prevent duplicate entries.Initial assessment and seriousness determination of case reports. Checking the consistency of case against the source document and entering any data found relevant during assessment.Coding adverse events, indications and patient history based on MedDRA, Coding of suspect products as well as concomitant drugs using CDD and WHO-DRUG dictionary.Narrative writing for Initial and Follow up reports. Ensure scientific rigor through accurate, complete and consistent data entry of adverse event reports from source documents with emphasis on timeliness and quality.Performing Labeling and Listedness of events with respect to CDS, IB, SPC and USPI. Generating follow up information if required.Processed Clinical Trial cases, Solicited Serious and Non Serious cases, Spontaneous Serious and Non Serious cases and Non Assessed Licensing Partner drugs cases. Processed safety reports of US cases and Non US cases reported globally.Processed cases for different Therapeutic areas. Major Teams: Immuno-infectious diseases, Respiratory, Oncology, Cardiovascular, Emergency medicines, Psychiatry and Mental Health.Work with country safety departments, Clinical Safety Scientists and Pharmacovigilance Leaders to ensure that reports are accurately collected, evaluated and databased. Alert manager to potential safety signals based on incoming case reports.Assist with related administrative and procedural activities as required or requested.Assists in the training of other Safety Processing Experts as necessary.Support DS&E Projects or database validation activities as required.