35 Icsr Jobs - Page 2

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...

We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer 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 fiel...

Hi We are hiring for ITES Company Role -Medical Reviewer Qualification : MBBS/MD only (MCI Certification is not mandate**) Experience Range : 1 to 7 Years Preferred Experience: Minimum of 1 years of experience in PV/ Clinical Research (drug safety) 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 Owne...

Qualification: MBBS Experience: 1 to 3 years Previous experience in medical review of ICSRs. Knowledge of safety databases, such as Argus, ARISg, or similar systems. Familiarity with medical coding dictionaries (e.g., MedDRA) and adverse event reporting standards (e.g., ICH E2B). Strong attention to detail and ability to work with complex medical data. Effective communication and interpersonal skills to collaborate with cross-functional teams and stakeholders. Key Responsibilities: Individual Case Safety Reports (ICSRs) Review: Conduct thorough and objective medical review of ICSRs received from various sources, including clinical trials, spontaneous reports, and literature. Assess the medic...

We are Hiring for Leading ITES Company for Medical Reviewer Profile Pls Apply, We shall call back the relevant profiles. Experience :- Min 1 years of experience in Medical Reviewer domain Job Description for Medical Reviewer 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 fiel...

Job Description: • Maintain Argus safety data base console, routine maintenance and work closely with Oracle and other Vendor during system upgrade • Review of Validation deliverables prepared by Vendor • Perform XML ICSR Data migration as part of Company Integration and/or Acquisition and merger. Support Database Vendor for Database to Database dump method for ICSR migration • Ensure Change controls are raised and closed in timely manner • Management of user licenses and delegation of role privileges with support from Oracle • Upgrade of dictionary, product list and Reporting Rules in Argus • Generation of all the type of Listings from Front of Argus • Revise and/or supervise revision and a...

Job Description The Pharmacovigilance (PV) Specialist, Case Processing manages individual case safety reports, performs initial case-level assessment of expectedness, confirms seriousness, composes accurate and thorough medical narratives, and generates queries for missing or unclear information. The PV Specialist ensures all cases meeting expedited regulatory reporting criteria are submitted to regulatory authorities in accordance with internal guidelines, Working Practices, SOPs, and applicable safety regulations. The PV Specialist maintains distinctive quality and commitment as the operating philosophy in carrying out all processes, and continually seeks out ways to enhance customer servi...

The PV Drug Safety Physician should be able to perform medical review of all types of individual case safety reports (ICSRs) by writing an expert company pharmacovigilance comment. The PV Drug Safety Physician maintains distinctive quality and commitment as the operating philosophy in carrying out all processes., and continually seeks out ways to enhance medical expertise in team both internally and externally. Role & responsibilities Provides medical review of safety events (pre-marketing, post-marketing, device, and drug) and/or other medically related information per assigned tasks and project-specific procedures. Provides input and review relevant safety information for signal detection ...

Position: Medical Safety Executive Department: Patient Safety Location: Ahmedabad Key Responsibilities Prepare and update Aggregate reports/ safety documents such as PADERs, PSURs, DSURs, RMPs, PBRERs, REMS, signal management documents and others, as applicable. Responsible for generation of applicable line listings from safety database, literature screening for inclusion, as applicable. Review and Identification of case reports and AOIs from literature and regulatory sources, as applicable. Independently creates and maintains Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post Market Clinical Follow Up Plans (PMCFP), PMCF Reports and Summary of Safety and Clinical Perfo...

Position Details: Designation: Assistant Manager Function: Pharmacovigilance Location: Navi Mumbai Role & responsibilities: Supporting in IT computer System validation activities of Safety Database and PV related applications Oversight activities for Pharmacovigilance activities, assess & Implement PV Regulatory Intelligence Managing ICSR Case processing activities, Procedural documents updates Participating in Internal and External Audits & Inspections preparations, mocks and presentation Perform oversight on vendor activities, SLAs and KPIs Knowledge of Aggregate Reports, PV Agreement life cycle management, Reconciliation & Regulatory Intelligence Knowledge of PSMF, Literature screening, A...