Pharmacovigilance Services Sr Analyst
Designation: Pharmacovigilance Services Sr Analyst
Qualifications:Bachelor of Aryurvedic Medicine And Surgery/Bachelor Degree in Life Sciences/Master Degree in Life Sciences
Years of Experience:5 to 8 years
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What would you do? Responsible for leading the Signal Management activities including weekly literature review, authoring of signal reports (Signal Management aid Review Team [SMART] reports) and project management of Safety Surveillance team (SST) meeting within the, agreed timeframes and accuracy, in compliance with business miles, standard operating procedures (SOP) and global regulatory requirements, all as documented ilil Quality documents as applicable
What are we looking for? o Minimum Education requirement: Degree in Life Sciences or Healthcare degree o Work experience requirements: Minimum of 3 years of Aggregate report experience with 3 years of signal management process experience o Working knowledge of Good Clinical Data Management Practices, GVP (Good Pharmacovigilance Practices), ICH Good Clinical Practices o Experience with MS Office products o Ability to work independently under tight time constraints o Good interpersonal skills and the ability to, operate effectively in an international environment
Roles and Responsibilities: o Literature review: On a weekly basis, review abstracts and articles for safety signals and/or for possible inclusion in the aggregate reports and record assessments in appropriate trackers. o Liaise with Global Safety Officer (GSO") Pharmacovigilance (PV) Scientist if a potential safety signal is identified upon review of the weekly alerts or in case of doubt. summary of articles of interest for GSO review with PV Scientist in copy in advance of the SMART meetings. o Complete the Literature Search Alert Tracker once GSO response received. o SMART Meeting: o Liaise with counterpart to identify the attendees and stakeholders for SMART meeting. o Schedule, SMART meetings and liaise with stakeholders and collate all the necessary data for review. o Draft the SMART report in the Electronic Data Management System (B-EAMS) using the applicable template. Compile and distribute the SMART report applicable stakeholders prior to, the SMART meeting. o Host the SMART meeting and document the review and any applicable action items in the SMART report. Update the SMART report and distribute it for review. Address the review comments and compile the draft for quality check. o Finalize the SMART report after addressing the QC comments and Route the final SMART report to GSO for approval. Enter information from the SMART meeting in the Safety Surveillance and Aggregate Reports (SSA) tracker. o SST Meetings: o Liaise with PV Scientist to debility the attendees and stakeholders for SST meeting. o Schedule the SST meetings and send Request for Information to the shareholders. To Compile the SST slide deck based on input from stakeholders, Prepare SST meeting minutes using the applicable template to document the action items discussed ilil the SST meeting. Distribute the minutes to stakeholders, finalize the minutes. Enter information from the SST meeting in the SSA tracker. o Perform the Signal management activities as per SOPs, Job Aids and guidelines as agreed during the SMART meetings and/or weekly team meeting o On -time escalation of any delayed inputs/ review comments/ endorsement as per process. o Archive the supporting documents used to, prepare the aggregate reports in the SharePoint or electronic repository as per the defined timelines o Provide responses to the query related to SMART reports as per the requested timeline o Complete the training as per the assigned timeline o Work with the IT systems where required (Tableau, BEAMS and SharePoint)
Bengaluru
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