Safety Aggregate Reporting Manager
IQVIA IndiaAnand, Republic Of India, IN15 days ago
Job descriptionand author responses to regulatory agency / Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Act as literature lead, back-up lead, reviewer / QCers to conduct 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 & / or signal detection relevance review. Author and / or contribute to literature deliverables for aggregate reports & / or signal management activities meeting strict regulatory timelines. Act as Signal Management Lead on large and / or complex post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Serve as subject matter expert across projects for complex data mining methodogies and algorithms on internal and external safety datasources. Oversee / set-up and update products' signaling strategies. Oversee / author and / or QC review all types of signal management deliverables. Oversee / 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. Accountable for full documentation and tracking of signals. At project level, maintain compliance, prepare metrics and KPI, present at audits and inspections. In a PV support role, act as functional lead and oversee / author and / or QC review safety responses to regulatory agencies / PRAC and justification documents to support labelling documents. Provide training to SARA staff for qualification on SARA deliverables May perform quality check of all assigned SARA deliverables be responsible for the quality of the final SARA deliverable to client regulatory, IQVIA regulatory reporting (RR), and regulatory authorties. Provide consultative guidance to internal and external stakeholders in the for all SARA deliverables. Act as mentor to and coach to project team staff and direct line reports.
Designation : Safety Aggregate Reporting Manager
Skill : Authoring Aggregate reports
Experience : 7+
Location : Across PAN India
Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for Safety Aggregate Report and Analytics (SARA) Center deliverables including but not limited to safety aggregate reports, literature surveillance, signal management activities and benefit risk management documents. Actively contribute to Lifecycle Safety global process initiatives and work in close collaboration with the safety customer delivery management team regarding project / client initiatives. Ensure team is following standard best-in-class practices established by the SARA infrastructure
- Serve as a stand-alone global lead for aggregate reporting, signal management.
- Lead, author and finalize aggregate reports, including but not limited to PBRERs / PSURs,
DSURs, PADERs, RMPs, REMS, ACOs, line listings
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),
Create a job alert for this search
Reporting Manager • Anand, Republic Of India, IN
Related jobs
- Promoted
Senior Manager Environment Health Safety
Astral AdhesivesAhmedabad, Gujarat, India Strategic & Leadership Responsibilities : .Develop and implement the overall safety roadmap for the chemical business aligned with corporate EHS policy.
Provide leadership and technical guidance to pl...Show moreLast updated: 20 days ago
- Promoted
Business Risk Manager (Technology)
RevolutNadiad, IN People deserve more from their money.More visibility, more control, and more freedom.Since 2015, Revolut has been on a mission to deliver just that.
Our powerhouse of products — including spending, ...Show moreLast updated: 30+ days ago
- Promoted
Manager - Captive Insurance
Selections HR Services Private LimitedNadiad, IN Finance & Accounting professional.Lead and manage a large team delivering middle-office services across Accounting, Treasury, Risk & Compliance.
Oversee and review management accounts, financial sta...Show moreLast updated: 1 day ago
- Promoted
- New!
Senior Manager - Risk and Compliance
Good Business LabVadodara, IN We use rigorous academic research to prove that worker well-being programs have business impacts.We develop market-ready, scalable interventions that benefit both workers and businesses.Our goal is...Show moreLast updated: 20 hours ago
- Promoted
Senior Safety Manager
HN SafalAhmedabad, Gujarat, India Job Title : Senior Safety Manager.As a Senior Safety Manager at HN Safal, you will lead and implement the organization’s safety management systems across all projects.
The role involves policy develo...Show moreLast updated: 1 day ago
- Promoted
Associate - US Assurance
Sikich IndiaAhmedabad, Gujarat, India The candidate will be overseeing and executing financial statement audits ensuring compliance with US GAAP.Experience in US GAAP general accounting and financial statement review is preferable.Siki...Show moreLast updated: 30+ days ago
- Promoted
Safety & Compliance Director
HN SafalAhmedabad, Republic Of India, IN Job Title : Senior Safety Manager.As a Senior Safety Manager at HN Safal, you will lead and implement the organization’s safety management systems across all projects.
The role involves policy develo...Show moreLast updated: 1 day ago
- Promoted
Business Risk Manager (Savings)
RevolutVadodara, IN People deserve more from their money.More visibility, more control, and more freedom.Since 2015, Revolut has been on a mission to deliver just that.
Our powerhouse of products — including spending, ...Show moreLast updated: 20 days ago
- Promoted
Assistant Manager - Environment Health & Safety
ConfidentialAhmedabad, India Manage work permit system like hot work, height work & confined space work etc.Preparing safety rules & checklist for safety.
To carry out safety induction training, firefighting training, mock dril...Show moreLast updated: 4 days ago
- Promoted
Assistant Manager - US Assurance
Sikich IndiaAhmedabad, Gujarat, India The candidate must have experience in US GAAP general accounting and financial statement review.The candidate will be overseeing and executing financial statement audits, guiding assigned staff in ...Show moreLast updated: 30+ days ago
- Promoted
Senior Safety Manager
ConfidentialAhmedabad, India Job Title : Senior Safety Manager.As a Senior Safety Manager at HN Safal, you will lead and implement the organization's safety management systems across all projects.
The role involves policy develo...Show moreLast updated: 4 days ago
- Promoted
Manager - Safety (Dahej A)
ConfidentialVadodara Understand the Company HSEF and process safety standards and draft out and implement the overall HSEF and Process safety Policy.
Budget for HSEF and Process Safety improvements Monitor HSEF and Proc...Show moreLast updated: 30+ days ago
- Promoted
HSE Leadership Specialist
HN SafalAhmedabad, Republic Of India, IN Job Title : Senior Safety Manager.As a Senior Safety Manager at HN Safal, you will lead and implement the organization’s safety management systems across all projects.
The role involves policy develo...Show moreLast updated: 1 day ago
- Promoted
Audit Manager- Healthcare
Citrin Cooperman India LLPAnand, IN Job Title : A&A Manager (Assisted Living / Nursing Home / Healthcare).Citrin Cooperman is one of the largest accounting and consulting firms in the United States, and 4th among mid-Atlantic firms, with ...Show moreLast updated: 15 days ago
- Promoted
EHS - Manager
ConfidentialAhmedabad, India Drive safety programs, compliance plans & training (First Aid, Lab Safety, Induction, Fire Safety, etc.Conduct internal / external safety audits & ensure EHS compliance.
Lead incident investigations &...Show moreLast updated: 4 days ago
- Promoted
Claims Manager General Insurance
ConfidentialAhmedabad Independently manage client accounts, maintaining excellent client relations and satisfaction.Oversee end-to-end claims handling from loss notification to final report submission.Coordinate with fi...Show moreLast updated: 30+ days ago
- Promoted
Senior Risk Management Leader
HN SafalAhmedabad, Republic Of India, IN Job Title : Senior Safety Manager.As a Senior Safety Manager at HN Safal, you will lead and implement the organization’s safety management systems across all projects.
The role involves policy develo...Show moreLast updated: 1 day ago
- Promoted
Site Safety and Risk Management Professional
HN SafalAhmedabad, Republic Of India, IN As a Safety Engineer at HN Safal, you will be responsible for ensuring safety systems are effectively implemented at our project sites.
You will work closely with the Safety Manager and project team...Show moreLast updated: 30+ days ago