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Sr Operations Specialist

Bengaluru, KA
Job Code:
  • Biotechnology & Science
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Job Details

Perform basic ad-hoc and standard searches, generate and distribute request specific tabulations, line listings, and/or reports.Performs aggregate report related activities on an as needed basis, including but not limited to, the followingVerify inclusion criteria for Periodic Report against the report requestExecute draft and final periodic line listings and tabulationsProduce final periodic line listings and tabulationsGenerate periodic report line listings for the following report typesPeriodic Safety Update Report (PSUR) Line Listing and TabulationsDevelopment Safety Update Report (DSUR)Periodic Adverse Drug Experience Report (PADER)Suspected Unexpected Serious Adverse Reaction (SUSAR) Line ListingsInvestigational New Drug Annual Report (IND)Perform data quality checks Other Activities, as required Perform User Acceptance Testing/CVT and complete required documentation Participate in the development and maintenance of Standard Operating Procedures, Standard Working Practices, Guidelines, and Supplemental Content, which detail the consistent and appropriate handling of all safety data requests sent to Safety Data Extraction, Pv Operations Participate in team meetingsWill make decisions regarding Priority of incoming requests (except legal and regulatory requests) Search strategies for basic and standard queries Daily prioritization of assigned work Work with Sr. Safety Analyst Specialist to prioritize daily workWill defer decisions regarding Priority of audit, inspection, regulatory, or legal requests Search strategies for advanced and expert queries->Policy decisions Education BS Computer Science, Statistics, Biology or related field or demonstrated experience. Strong working knowledge of relational databases Intermediate to advanced skills in the MS Office SuitePharma Experience Previous pharmaceutical experience and understanding of safety regulations Working knowledge of applicable global, regional and local regulatory requirements; i.e., Good ClinicalPractice (GCP) and International Conference on Harmonization (ICH) guidelines Knowledge of safety database applications Basic understanding of medical terminology including WHO, MedDRA preferred Working knowledge of AE processingWork Management Ability to Prioritizing workload (ability to multi-task) and meet strict deadlines Ability to work independently or as part of a team. Ability to utilize appropriate initiative and autonomy in achieving objectives Ability to escalate issues as appropriateOther skills Problem solving abilities and independent decision making skills. Clear concise documentation skills. Strong written and verbal communication skills. Demonstrated understanding of basic statistical principals. Strong Interpersonal skills Possess great attention to detail Demonstrated ability to apply statistical methodologies to create reports and graphs Ability to support UAT/CVT activities and related user testing documentation
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 3-8


Application Programming | Quality Assurance/Testing | Software Engineer
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