16 Safety Database Jobs

Role & responsibilities: 1 yr of Clinical Practice experience & 1 year PV experience as Medical reviewer Should have sound clinical knowledge Should be familiar with: Listedness Assessment Causality assessment Seriousness Assessment Should be able to write overall assessment (company comments) Able to raise appropriate medical queries Databases: Argus is good but any other DB is also fine

Job Overview Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff. Essential Functions Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information determining initial/update status of incoming events d...

As a Safety & PV Specialist I (Japanese Language Expert) at Syneos Health, your role will be crucial in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. Here is a detailed overview of your responsibilities: - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assist in processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. - Triage ICSRs, evaluate data for completeness, accuracy, and regulatory report ability. - Enter data into safety database and code events, medical history, concomitant medications, and tests. - Compile complete ...

Job Overview The Workflow Analyst will hold the responsibilities of performing drug safety and pharmacovigilance support activities as assigned. Summary Of Responsibilities Segregate cases received as per priority and due dates in the database worklist. Assign cases to case processing team based on the priority and availability of resources in consultation with Team Lead or designee. Enter data into the Master case tracking sheet. Track and monitor the case progression with help of case tracking sheet. Follow up with associates and/or team leads to ensure timely completion of review and ensure case prioritization. Reconciliation of TAT data on a daily basis to ensure all the cases are assign...

Job Overview Job Overview - (Looking for candidates with < 30 days notice period and experience in LSMV / ArisG Database) Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations Standard Operating Procedures (SOPs) and internal guidelines under guidance and support of senior operation team members. Essential Functions To Prioritize and complete the assigned trainings on time. Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. To perform Pharmacovigil...

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details Screening scientific literature by using the internal search mechanism and/or by making use of external tools and providers. Classification of references of safety-relevant publications. To keep track of the internal literature ordering process. Data entry of literature reports into the safety database. Pre...

Description Safety & PV Trainee Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating...

As a Safety & PV Trainee at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients involved in clinical trials and post-marketing programs. By entering information into PVG quality and tracking systems, processing ICSRs, and maintaining safety tracking, you will contribute to the accurate and timely reporting of safety data. Your responsibilities will include: - Entering information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assisting in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. - Triaging ICSRs, evaluating ICSR data for complet...

Job Responsibilities: - Enter information into PVG quality and tracking systems for receipt and tracking ICSR as required. - Assists in the processing of ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans as required. - Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. - Enters data into safety database. - Codes events, medical history, concomitant medications, and tests. - Compiles complete narrative summaries. - Identifies information to be queried and follows up until information is obtained and queries are satisfactorily resolved. - Assists in the generation of timely, consistent, and accurate repo...

JOB DESCRIPTION: Primary Job Function: The position holder is responsible for retrieving data from the Global Safety Database and associated systems. Core Job Responsibilities: Responsibilities include but are not limited to: Provide business support for other functions in GPV by providing safety data in appropriate quality, timeline, and format. Perform pre-defined validated queries (e.g., PSUR listings) or develop new ad hoc queries. Supervisory/Management Responsibilities: Direct Reports: None Indirect Reports: None Position Accountability/Scope: Producing high-quality safety data reports in line with applicable guidelines and Abbott SOPs. Works with supervision and guidance. Minimum Educ...

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Senior Analyst Qualifications: Any Graduation,Bachelor of Pharmacy,Any Graduation Years of Experience: 5 to 7 years Language - Ability: Japanese - Elementary About Accenture Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000...

As a Safety Associate, you will be responsible for reviewing, assessing, and processing safety data and information across service lines. Your key duties will involve distributing reports/data to internal and external parties, ensuring compliance with applicable regulations, SOPs, and internal guidelines, and working under the guidance of senior operations team members. You will need to prioritize and complete assigned trainings on time and process safety data according to regulations, guidelines, SOPs, and project requirements. Your role will also include performing pharmacovigilance activities such as collecting and tracking incoming Adverse Events (AEs)/endpoint information, determining t...

Hi We are hiring for the leading ITES Company for the Medical Reviewer Role. Qualification - MBBS/MD is Must (Full TIme) Job Overview: The Medical Reviewer is responsible for the evaluation and analysis of clinical data to ensure accuracy, compliance with regulations, and the highest quality standards. This role involves reviewing clinical trial data, medical documentation, and regulatory submissions to support the approval of new medical products and therapies. Key Responsibilities: Clinical Data Review : Evaluate clinical trial data for completeness, accuracy, and adherence to protocols. Ensure data integrity and consistency across various documents and databases Medical Documentation: Rev...

Hi We are Hiring Leading ITES Company for Medical Reviewer Role. Please go through the JD and Apply Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the ca...

Hi We are hiring for the leading ITES Company for the Medical Reviewer Role. Qualification - MBBS/MD is Must (Full TIme) Job Overview: The Medical Reviewer is responsible for the evaluation and analysis of clinical data to ensure accuracy, compliance with regulations, and the highest quality standards. This role involves reviewing clinical trial data, medical documentation, and regulatory submissions to support the approval of new medical products and therapies. Key Responsibilities: Clinical Data Review : Evaluate clinical trial data for completeness, accuracy, and adherence to protocols. Ensure data integrity and consistency across various documents and databases Medical Documentation: Rev...

Hi We are Hiring Leading ITES Company for Medical Reviewer Role. Please go through the JD and Apply Job Description: Author a company clinical comment (CCC) for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: -Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. -Detail any requests for changes to the ca...