607 Financial Reports jobs in India

• Review Site Visit Reports (SVRs) to ensure they meet or exceed quality standards and support goals of quality, subject safety, data integrity and regulatory compliance. Use tools and techniques to ensure the efficient and effective review of Site Visit Reports and their associated attachments, in compliance with IQVIA SOP, ICH/ GCP guidelines, and protocol requirements

• Essential Functions
• Oversee a caseload of SVRs for assigned studies, ensuring compliance to the protocol, processes, timelines, IQVIA/applicable SOPs, and GCP guidelines.
• Review SVRs to ensure findings requiring corrective and /or preventative action plans are documented and followed up to resolution, to ensure high quality reports.
• Participate on the project team for all SVR review activities and identifies and escalate CRA and /or site issues, relevant trends, and related risk factors to the project team and appropriate parties in a timely manner to optimize quality of project delivery.
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• Provide guidance to Clinical Project Managers (CPMs) at project start-up and throughout the study and partner with the project team members to decrease the level of corrections/additions needed on reports by providing insight and training of the SVR annotations.
• Identify and track the project team compliance to SOPs for submission and approval of the SVRs through communication with the CRAs and line managers.
• 
  
• Participate in meetings with project team to discuss any SVR review issues illustrative of quality/performance deficiencies across PIs/sites and CRAs. Assist with identification of the trends emerging from the Issue Escalation Log.
• Provide coaching to CRAs to decrease the level of corrections/additions needed on reports.
• Provide quality improvement support such as quality checks, data trending, providing back up support and mentoring and coaching of junior staff members.
• May take on special project assignments related to function/corporate initiatives.
• Qualifications
• Bachelors Degree Healthcare or other scientific discipline or educational equivalent Req
• 7-8 years of Clinical Research experience, including a minimum of 3 to 4 years on-site monitoring experience Req Or
• Equivalent combination of education, training and experience. Req
• Strong knowledge of and skill in applying, applicable clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Through knowledge and understanding of the Clinical monitoring processes and sound knowledge of clinical trial systems and applications
• Demonstrated skill in understanding and executing complex study designs as well as multiple studies
• Strong written and verbal communication skills.
• Effective time management and organizational skills, and the ability to manage competing priorities
• Ability to work independently with good analytical and problem solving skills
• Demonstrated ability to work across cultures and geographies with a high awareness and understanding of cultural differences
• High quality orientation, with a focus on attention to detail
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Fluent in English, both spoken and written.

What you ll do at Ather:

• Be a key member of the Finance Controllership Team and primarily be responsible for book closures and period financial reporting.
• Support in preparation of financial statements schedules - monthly, quarterly and yearly.
• Actively manage sub-processes of Fixed Asset. This includes end-to-end ownership from a process and reporting perspective.
• Ensure timely accounting and reporting for all investments and borrowings along with compliance with all loan covenants.
• Actively run balance-sheet reconciliation routines; periodic GL scrutiny, periodic review of Chart of Accounts, prepare back-up workings for Ind AS adjustments, build strong internal controls for day-to-day compliances, audits, etc. and periodic attestations/testing.
• FAME and EMPS incentive accounting and reconciliation.
• Assist in building scalable ERP platforms and strong ICFR framework
• Work closely with auditors on quarterly, interim and final statutory audits.
• Work closely on internal and tax audit engagements
• Support the R2R lead in various submissions for due diligence projects for fund (equity/debt) raising.
• Coordinate within the Finance team for all monthly and quarterly submissions to management and the Board.

H ere s what we are looking for:

• In-depth experience in finance processes and IND-AS reporting.
• Strong work experience in monthly accounting closure/audits of a manufacturing/retail entity.
• Proficiency in Microsoft Excel
• Experience in Controllership / Accounting / Auditing in a listed manufacturing or retail entity or Big 4 firms.
• Experience in accounting applications - SAP, BPC, Oracle, etc.
• Ability to build successful relationships across stakeholders.
• Ability to effectively manage time, prioritise tasks, and work within strict timelines.

You bring to Ather:

• A Chartered Accountant qualification.
• Relevant work experience of 3-5 years (post qualification)

Job title : Safety Aggregate Report Specialist 2

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- 9 years relevant work experience. Pref

Job title : Safety Aggregate Report Specialist 2

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- 9 years relevant work experience. Pref

Job title : Safety Aggregate Report Specialist 2Work experience : 3+Must have skills : Authoring Aggregate reportsLocation: Across PAN IndiaJob OverviewApply 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- 9 years relevant work experience. Pref

Job title : Safety Aggregate Report Specialist 2

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- 9 years relevant work experience. Pref

Job title : Safety Aggregate Report Specialist 2

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- 9 years relevant work experience. Pref