Periodic Report Specialist

2 weeks ago

Hyderabad, Telangana, India Amgen Inc Full time ₹ 9,00,000 - ₹ 12,00,000 per year

This position plays a role in the authoring, compilation and peer review of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e.g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. In compliance with global regulatory requirements. This role supports the end-to-end writing and documentation process and ensures timelines are met.

Key Responsibilities:

  • Compilation and authoring of PASRs
  • Coordinate and schedule all meetings with cross-functional stakeholders to ensure effective collaboration and alignment
  • Drive report timelines and escalate risks or delays to team leads or management
  • Collaborate with cross-functional stakeholders and external business partners to collect PASR contributions and compile into PASR template.
  • Author safety content for all PASRs in collaboration with Therapeutic Area Safety scientists
  • Conduct peer QC of safety authored sections, coordinate Amgen review and resolve comments and initiate approval workflows.
  • Maintain and archive accurate records and documentation throughout the report process.
  • Review and approve published report versions (i.e. blinded, unblinded, EU FDA, Rest of World).
  • Manage report distribution to Contract Research Organizations (CROs) and Business Partners (BPs)
  • Ensure adherence to established timelines, regulatory guidelines and applicable standards, styles, guidelines and processes
  • Peer review/quality review of all PASRs within established timelines with adherence to applicable guidelines and processes, using appropriate checklists
  • Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards
  • Generate PASR metrics, including Key Compliance Indicators (KCIs) and Key Performance Indicators (KPIs).
  • Literature Management Process
  • May assist with Literature Management activities as required

  • Periodic Report Safety QC Reviewer

    2 weeks ago

    Hyderabad, Telangana, India Amgen Inc Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    The primary responsibility of this role is to perform quality control reviews of of Amgens Periodic Aggregate Safety Reports (PASR) e.g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER),...

  • HR Reporting Specialist

    4 days ago

    Hyderabad, Telangana, India Cantor Fitzgerald Full time ₹ 5,00,000 - ₹ 12,00,000 per year

    Position Summary:We are seeking an experiencedHR Reporting Specialistwith expertise inOracle OTBI (Oracle Transactional Business Intelligence)to support our organization's Oracle HCM reporting requirements. The successful candidate will be responsible for designing, developing, and maintaining reports and dashboards that provide critical workforce insights...

  • Record To Report Specialist

    7 days ago

    Hyderabad, Telangana, India Databeat Full time ₹ 40,00,000 - ₹ 80,00,000 per year

    About the Role:We are looking for a skilled and detail-oriented Record to Report (R2R) Specialist to join our finance team. The ideal candidate will be responsible for end-to-end accounting processes including payments, reconciliations, month-end close, and financial reporting, while ensuring accuracy, compliance, and strong stakeholder communication.This...

  • Pharmacovigilance Reporting and Analytics Specialist

    5 days ago

    Hyderabad, Telangana, India Opella Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job title:Pharmacovigilance Reporting and Analytics SpecialistLocation: HyderabadOpella is the self-care challenger with the purest andthird-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.Our mission is to bring health in people's hands bymaking self-care as simple as it should be. For half a billion...

  • Research specialist and technical report writer

    2 days ago

    Hyderabad, Telangana, India AEC Full time ₹ 6,00,000 - ₹ 8,00,000 per year

    Job Title:Research specialist and technical report writer for an Engineering FirmLocation:Remote Employment Type:Full-timePosition OverviewSeeking a research specialist and technical report writer to support our team of Civil and Environmental Engineers conducting commercial property assessments. Preference will be given to candidates with a background in...

  • Data & Reporting Specialist

    2 weeks ago

    Hyderabad, Telangana, India MarketStar Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    If you are a current employee who is interested in applying to this position, please navigate to the internal Careers site to apply.Disclaimer: MarketStar is committed to ensuring integrity and transparency in our recruitment practices. We DO NOT charge any fees at any stage of the recruitment process. In case you receive any unsolicited requests for...

  • Record To Report

    7 days ago

    Hyderabad, Telangana, India Whyflex Human Capital Solutions Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    Role & responsibilitiesSubject Matter Expert - R2RQualifications:Bachelor/Post Graduate Degree in Commerce (exclusion BE/B.Tech/MCA/Arts and Science Graduates).With experience in Record to Report between 4-8 yearsResponsibilities:Preparing the workings for passing complex journal entries, reviewing complex journal entries, performing an analysis of fixed...

  • DevOps Specialist

    2 weeks ago

    Hyderabad, Telangana, India LTIMindtree Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Role: Ansible SpecialistExperience: 5 to 8 YearsJob Location: Hyderabad, PuneHybrid ModeFTE with LTIMindtreeNotice Period: Immediate to 30 daysPlease do not apply Notice Period with more than 30 daysMandatory Skills:Python+ Ansible+ Automation+ Docker+ Kubernetes+ Shell scriptingThanks & Regards,Prabal Pandey

  • Workday Reporting

    2 weeks ago

    Hyderabad, Telangana, India Wipro Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job DescriptionJob Title: Workday ReportingReq Id: 101444City: HyderabadState/Province: TelanganaPosting Start Date: 10/29/25Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients' most complex digital transformation needs. Leveraging our...

  • LIMS Specialist

    1 week ago

    Hyderabad, Telangana, India Swift Strategic Solutions Inc Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Our technology services client is seeking multipleLIMS Specialistto join their team on a Full Time basis. Below are further details about the role:Role: LIMS SpecialistExperience: 3-8 YearsLocation: PAN IndiaNotice Period: Immediate- 15 DaysMandatory Skills: LIMS Labware, Support experience L2/L3.Job Description:Strong Technical Knowledge on Empower other...