This job offer is not available in your country.
Safety Aggregate Reporting Manager
IQVIA Indiatiruppur, tamil nadu, in30+ 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
Safety Manager • tiruppur, tamil nadu, in
Related jobs
- Promoted
Associate Director, Safety Operations
IQVIA IndiaTiruppur, IN Associate Director, Safety Operations.Lead Safety staff responsible for Safety Operations processing in alignment with departmental and corporate standards.
Contribute to Global initiatives.Work in ...Show moreLast updated: 4 days ago
- Promoted
EHS Enablon Technical Consultants
ADR Application Development Resources, Inc.Erode, IN If you are interested, please email me your CV at linda.There are 4 openings for EHS Technical Consultants in India It is a Remote positions.
Enablon solution will support internal and external r...Show moreLast updated: 12 days ago
- Promoted
SAP Analytics & Reporting
RED GlobalCoimbatore, IN SAP Analytics and Reporting Analyst – Global Development.Until September 2026, with potential for multiple extensions.Analytics and Reporting Analyst.
This role will focus on enabling effective deci...Show moreLast updated: 4 days ago
- Promoted
Lead Regional Compliance Specialist
Securitas GroupTiruppur, IN Lead Regional Compliance Specialist - APAC.India – open to Chennai / Hyderabad / Pune.We are a dynamic, dedicated team that provides management and support for a global guarding services account that s...Show moreLast updated: 22 days ago
- Promoted
Actuarial Life Pricing
EliteRecruitmentsCoimbatore, IN Ideal for professionals with hands-on experience in individual life product pricing, model development, and IRDAI filing.
Conduct feasibility studies for.Collaborate with cross-functional teams incl...Show moreLast updated: 2 days ago
- Promoted
Actuarial Life GGY AXIS
EliteRecruitmentsErode, IN We are hiring for a client-facing.This role involves supporting life actuarial valuation, assumption review, model development, and reporting — with a strong focus on.
This is an excellent opportuni...Show moreLast updated: 2 days ago
- Promoted
Finance Review Manager
CoatsTiruppur, IN Coats is a world leader in thread manufacturing and structural components for apparel and footwear, as well as an innovative pioneer in performance materials.
These critical solutions are used to cr...Show moreLast updated: 20 days ago
- Promoted
Central Monitor II
Precision Medicine GroupCoimbatore, IN The Central Monitor II will play a key role in ensuring the quality and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk manag...Show moreLast updated: 16 days ago
- Promoted
Oracle HFM Technical Lead
Penta ConsultingErode, IN Penta Consulting are a technology resource solutions provider to leading OEMs across the EMEA region.We are currently working with our leading client in the search for a Technical Team Lead, focusi...Show moreLast updated: 22 days ago
- Promoted
Business Risk Manager (Technology)
RevolutErode, 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: 22 days ago
- Promoted
Senior Policy Advisor
GrayQuestErode, IN In this role, you will consult with families to understand their health and financial requirements, explain policy options in simple terms, and recommend the most suitable insurance solutions.The i...Show moreLast updated: 4 days ago
- Promoted
Director Environment Health Safety
Quaker HoughtonErode, IN At Quaker Houghton, we are experts in the development, production and application of industrial process fluids, lubricants, and coatings for the manufacturing industry.
We have been an integral part...Show moreLast updated: 4 days ago
- Promoted
Financial Reporting (CA)
LTIMindtreeErode, IN LTIMindtree is a global technology consulting and digital solutions company that enables enterprises across industries to reimagine business models, accelerate innovation, and maximize growth by ha...Show moreLast updated: 13 days ago
- Promoted
Property & Casualty CRE Insurance Specialist (Contract-to-Full Time)
Stealth CompanyErode, IN This is an opportunity to collaborate with some of the most successful and forward-thinking stakeholders in the industry.
More details on the project will be shared once we connect.We’re seeking som...Show moreLast updated: 1 day ago
- Promoted
Ecommerce Reporting and Analytics Lead
MultiplyMiiErode, IN Ecommerce Reporting and Analytics Lead.Our client is a growth-focused firm that builds and scales high-performing e-commerce brands across Amazon, Shopify, and Walmart.
With a strong track record of...Show moreLast updated: 4 days ago
- Promoted
Risk Analyst
TurnoTiruppur, IN Development, Implement and Review of Credit Risk Models & Associated Frameworks in an unsecured rural / semi-urban lending context.
Implement & Monitor Credit Risk strategies across the lending life c...Show moreLast updated: 23 days ago
- Promoted
Senior Manager
PwCTiruppur, IN A career within General Consulting services, will provide you with the opportunity to help clients seize essential advantages by working alongside business leaders to solve their toughest problems ...Show moreLast updated: 2 days ago
- Promoted
Reporting Specialist
Hogarth Studios IndiaTiruppur, IN We are seeking a highly analytical and detail-oriented.Operations Reporting Specialist.In this critical role, you will be instrumental in transforming raw operational data into actionable insights,...Show moreLast updated: 4 days ago