1,210 Financial Reports jobs in India
Periodic Report Specialist
Posted today
Job Viewed
Job Description
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 Specialist
Posted today
Job Viewed
Job Description
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
**Basic Qualification and Experience:**
+ Total experience: 5-9 years
+ At least 2-3 years in Periodic report writing.
+ Bachelor's or Master's degree in Life Sciences or Pharmacy.
Safety Aggregate Report Specialist 2
Posted 2 days ago
Job Viewed
Job Description
Job title : Safety Aggregate Report Specialist
Work experience : 3+
Must have skills : Authoring Aggregate reports
Location: Across PAN India
Job Overview
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
Essential Functions
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
Participate in internal and external audits and inspections, as required.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
Serve as the interface between the global project lead and the working team
conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
Provide mentorship and training to less experienced resources.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns
participate in project review meetings with management
communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
Support and/or contribute to technology / innovation activities.
Qualifications
Bachelor's Degree In a Scientific or Healthcare discipline Req
3- 5 years relevant work experience preffered.
Safety Aggregate Report Specialist 2
Posted 2 days ago
Job Viewed
Job Description
Job title : Safety Aggregate Report Specialist
Work experience : 3+
Must have skills : Authoring Aggregate reports
Location: Across PAN India
Job Overview
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
Essential Functions
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
Participate in internal and external audits and inspections, as required.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
Serve as the interface between the global project lead and the working team
conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
Provide mentorship and training to less experienced resources.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns
participate in project review meetings with management
communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
Support and/or contribute to technology / innovation activities.
Qualifications
Bachelor's Degree In a Scientific or Healthcare discipline Req
3- 5 years relevant work experience preffered.
Safety Aggregate Report Specialist 2
Posted today
Job Viewed
Job Description
Work experience : 3+
Must have skills : Authoring Aggregate reports
Location: Across PAN India
Job Overview
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
Essential Functions
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
Participate in internal and external audits and inspections, as required.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
Serve as the interface between the global project lead and the working team
conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
Provide mentorship and training to less experienced resources.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns
participate in project review meetings with management
communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
Support and/or contribute to technology / innovation activities.
Qualifications
Bachelor's Degree In a Scientific or Healthcare discipline Req
3- 5 years relevant work experience preffered.
Safety Aggregate Report Specialist 2
Posted 1 day ago
Job Viewed
Job Description
Job title : Safety Aggregate Report Specialist
Work experience : 3+
Must have skills : Authoring Aggregate reports
Location: Across PAN India
Job Overview
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
Essential Functions
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
Participate in internal and external audits and inspections, as required.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
Serve as the interface between the global project lead and the working team
conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
Provide mentorship and training to less experienced resources.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns
participate in project review meetings with management
communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
Support and/or contribute to technology / innovation activities.
Qualifications
Bachelor's Degree In a Scientific or Healthcare discipline Req
3- 5 years relevant work experience preffered.
Safety Aggregate Report Specialist 2
Posted 1 day ago
Job Viewed
Job Description
Job title : Safety Aggregate Report Specialist
Work experience : 3+
Must have skills : Authoring Aggregate reports
Location: Across PAN India
Job Overview
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
Essential Functions
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
Participate in internal and external audits and inspections, as required.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
Serve as the interface between the global project lead and the working team
conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
Provide mentorship and training to less experienced resources.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns
participate in project review meetings with management
communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
Support and/or contribute to technology / innovation activities.
Qualifications
Bachelor's Degree In a Scientific or Healthcare discipline Req
3- 5 years relevant work experience preffered.
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Safety Aggregate Report Specialist 2
Posted today
Job Viewed
Job Description
Job title : Safety Aggregate Report Specialist
Work experience : 3+
Must have skills : Authoring Aggregate reports
Location: Across PAN India
Job Overview
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
Essential Functions
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
Participate in internal and external audits and inspections, as required.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
Serve as the interface between the global project lead and the working team
conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
Provide mentorship and training to less experienced resources.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns
participate in project review meetings with management
communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
Support and/or contribute to technology / innovation activities.
Qualifications
Bachelor's Degree In a Scientific or Healthcare discipline Req
3- 5 years relevant work experience preffered.
Safety Aggregate Report Specialist 2
Posted today
Job Viewed
Job Description
Work experience : 3+
Must have skills : Authoring Aggregate reports
Location: Across PAN India
Job Overview
Apply knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents.
Essential Functions
Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA).
Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings
author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products' signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals.
In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed.
Participate in internal and external audits and inspections, as required.
Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics.
Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented.
Serve as the interface between the global project lead and the working team
conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members.
Provide mentorship and training to less experienced resources.
Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns
participate in project review meetings with management
communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP).
Support and/or contribute to technology / innovation activities.
Qualifications
Bachelor's Degree In a Scientific or Healthcare discipline Req
3- 5 years relevant work experience preffered.
Financial Analysis Specialist
Posted today
Job Viewed
Job Description
- Will have ownership of P&L, FP&A activities, deal approvals, and business support to client delivery executive and client executive.
- Individual would drive various projects / initiatives in the job role - Own and manager customer P&L including Reporting, Forecasting, Outlook, variance analysis
- Provide subject matter expertise to business partners -contributes to the development of new techniques and plans within area of expertise.
- Provides insights into business performance through regular interactions with business partners.
- Understanding of the deal model & related revenue/ cost recognition implications.
- Integrates trends, data and information into Plans, Forecasts/ Outlook and also in other deliverables and recommendations.
- Complete understanding of customer contracts for the accounts being managed.
- Develop a good working relationship with the business partners and across other functions - accounting, FP&A, Sales comp team, etc.
- Oversight of AR and revenue recognition activities.
- Work on abstract and complex problems requiring evaluation of intangible variations
- Detailed analysis of Rev and costs and provide feedback to business on operational efficiency opportunities
- Manage special projects and program execution - guide business partners to drive completion."