[Skip to main content](#main-content) [OpenNash Jobs](https://jobs.opennash.com/) [Hiring report](/reports/hiring/) · [All Amgen jobs](https://jobs.opennash.com/companies/amgen/) · [Search jobs](/search/) Amgen · India - Hyderabad # Sr Assoc Pharmacovigilance Operations India - Hyderabad Senior individual contributor Healthcare & Clinical Listed on Amgen’s official careers site. Listed as of October 18, 2026. Check that it is still open and apply there. [Apply on Amgen’s careers site →](https://amgen.wd1.myworkdayjobs.com/Careers/job/India---Hyderabad/Sr-Assoc-Pharmacovigilance-Operations_R-251859) [OpenNash Jobs](https://jobs.opennash.com/) / [Amgen](https://jobs.opennash.com/companies/amgen/) / Sr Assoc Pharmacovigilance Operations ## Job description Career Category Safety ### Job Summary Responsible for: Support vendor oversight of all case intake and processing activities Case review Escalation of case level issues Support convention-related training delivery Manage queries on Intake, triage, and data entry of ICSRs Reporting decision for submitting all expedited safety reports to FDA/EMA Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts Reporting of ICSRs within time frames determined by regulations and contracts Support BP reconciliation as required by safety agreement Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor. ​ Key Activities Support ICSR processing to ensure high-quality cases in a timely manner to meet all worldwide regulatory authority requirements Perform case review Perform US case follow up activities Support the development and delivery of convention-related training material Review and respond to AE intake, triage, and submission queries in a timely fashion Initiate unblinding as requested Select cases for reporting to FDA/EMA and business partners based on detailed knowledge of legislation & contractual agreements Ensure compliance of reporting activities with timelines and criteria Interface with local office staff, vendors, and business partners for case processing as necessary Escalation of data entry issues identified Provide LAO E2B support (nullification, redistribution) Perform BP reconciliation as required by safety agreement Support the ICSR literature review process Support reportable event reconciliation for Amgen-sponsored clinical trials. Support other case processing functions as required. - Knowledge and Skills Understanding of global regulatory requirements for pharmacovigilance - Familiarity with clinical development process Case processing experience with demonstrated high case level productivity and quality Attention to detail - Proficiency in safety system Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook Education & Experience (Basic) - Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and 6 years of directly related experience OR High school diploma / GED and 8 years of directly related experience. ## At a glance - Posted by the employer: Not stated - First seen by OpenNash: Aug 21, 2026 - Last checked: Oct 18, 2026 - Listed for: 58 days - Location: India - Hyderabad[Apply on Amgen’s careers site →](https://amgen.wd1.myworkdayjobs.com/Careers/job/India---Hyderabad/Sr-Assoc-Pharmacovigilance-Operations_R-251859) ## More jobs at Amgen ### [Associate Healthcare Community Contracting](https://jobs.opennash.com/companies/amgen/jobs/c90b3ec43a4c9838de7f/) India - Hyderabad ### [Global Safety Associate Medical Director](https://jobs.opennash.com/companies/amgen/jobs/b6064c6b939d418999e4/) India - Hyderabad ### [Healthcare Community Contracting Manager](https://jobs.opennash.com/companies/amgen/jobs/4b0381c43cd63180391e/) India - Hyderabad ### [Healthcare Community Contracting Sr Associate](https://jobs.opennash.com/companies/amgen/jobs/6717afc695e7c630b4b1/) India - Hyderabad ### [Manager Clinical Supply Chain - Development Supply Chain Operational Support](https://jobs.opennash.com/companies/amgen/jobs/21ffbf88dec05a96f050/) India - Hyderabad ## Similar jobs at other companies ### [Pharmacovigilance Physician](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/d3f042edf058ed84df7a/) Thermo Fisher Scientific · Remote, India ### [FSP Pharmacovigilance Coordinator](https://jobs.opennash.com/companies/thermo-fisher-scientific/jobs/ad16813aee4a1d425d27/) Thermo Fisher Scientific · Remote, Philippines ### [Senior Scientist Pharmacovigilance Single Case Processing, Standards](https://jobs.opennash.com/companies/haleon/jobs/bd0cf2a7ba8fb4137653/) Haleon · Warsaw Cirrus, Warsaw, Poland ### [Lead/Sr Assoc / Assoc Software Engineer — Portfolio Insights Platform, Wealth Management](https://jobs.opennash.com/companies/jpmorganchase/jobs/29fc37197c9c09044047/) JPMorganChase · LONDON, United Kingdom ### [Gestionnaire principal(e), Pharmacovigilance Corporative/ Senior Manager, Corporate Pharmacovigilance](https://jobs.opennash.com/companies/mckesson/jobs/354670ea1c7f0f593acc/) McKesson OpenNash lists jobs from employers’ own careers sites and does not handle applications. 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