Pharmacovigilance Leads

Pharmacovigilance Leads

Golden Opportunities Private Limited
Mumbai
8 - 12 Years
Not Specified

Job Description


Description
Pharmacovigilance Job Description: we are looking for 8 + years of work experience into Pharmacovigilance in ICSR. Ensure completion of basic training in case handling. Begin and complete the process for competency sign off for A category cases. Ensure that the case is QREd before closure in case the administrator is not signed off for A category cases. Enter initial and follow-up information for individual adverse event case reports of low business risk onto the global Patient Safety database, using data interpretation, coding and writing skills in accordance with the current Data Entry Process Instructions and associated SOPs and OPI to ensure consistency of case entry and high data quality standards. Select the cases from the relevant mailbox (Clinical trial, Post Marketed) and enter the Patient Safety Administrator persons name in relevant field in mailbox tracker. Begin to enter the case in Sapphire completing Log pages 1 and 2, save the information to generate case ID. Document the Sapphire case ID in mailbox tracker. Assign the case to a case owner as per Global Case Handling SOP. Continue entering the case - if the Patient Safety Administrator has been signed off on category A cases if it is required. Ensure compliance with global and local procedural documents and local implementation of AZ policies, processes and procedures. Perform all activities within the required timeframes to ensure regulatory compliance. Support a performance-driven culture. The case handler could move on to B cases if the team leader assess them to be ready after A sign off.There is no B category in the Clinical Trial Process. All new recruits will initially perform the responsibilities as a Patient Safety Administrator. Patient Safety Administrator can also act as a Mailbox Handler, Mailbox Handler Back up, License Partner Case Reporting personnel or Trainer, and also can work as a Literature Case Handler. If the additional task(s) requires specific training/hands-on-training it has to be completed before taking over it. Looking for LifeScience Graduate. Candidate should have Team Handling Experience.

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