Safety Aggregate Reporting Manager
IQVIA Indiavijayapura, rajasthan, 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
Manager • vijayapura, rajasthan, in
Related jobs
We’re looking for a detail-oriented audit professional with hands-on experience in.PM – 1 : 00 AM IST (Canada aligned).Execute audit procedures including substantive & controls testing.Support compli...Show moreLast updated: 1 day ago
- Promoted
Business Risk Manager (Technology)
Revolutvijayapura, rajasthan, 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
Sr SAP EHS Functional
KATBOTZ®vijayapura, rajasthan, in We are seeking a highly skilled.SAP Environment, Health, and Safety (EHS) solutions.The ideal candidate will have deep knowledge of SAP EHS modules, regulatory compliance requirements, and process ...Show moreLast updated: 2 days ago
- Promoted
Third-Party Risk Management
Live Connectionsvijayapura, rajasthan, in Manager – Information Security (Third-Party Risk Management).Educational Qualifications / Certifications.Bachelor’s degree in Computer Science, Engineering, or a related field (or equivalent work e...Show moreLast updated: 1 day ago
- Promoted
Audit Manager- Healthcare
Citrin Cooperman India LLPvijayapura, rajasthan, 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: 17 days ago
- Promoted
- New!
Zonal Training Manager
Anand Rathi Share and Stock Brokers Ltdvijayapura, rajasthan, in The Zonal Trainer is responsible for designing, implementing, and delivering training programs within a designated geographical zone.
They ensure that employees within their zone are equipped with t...Show moreLast updated: 9 hours ago
- Promoted
Business Risk Manager (Savings)
Revolutvijayapura, rajasthan, 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
- New!
Manager / Sr Manager Portfolio – EMENA Portfolio Alliance Management
Intas Pharmaceuticalsvijayapura, rajasthan, in Specific Job Responsibilities : .Portfolio Pipeline development tracking & Alliance management.Responsible for working closely with internal and external stakeholders for planning, executing, monitor...Show moreLast updated: 9 hours ago
- Promoted
Manager- SACCR / Counterparty Credit Risk
Evalueservevijayapura, rajasthan, in Elevate Your Impact Through Innovation and Learning.Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 50...Show moreLast updated: 15 days ago
- Promoted
Sr. Associate - Risk Advisory (HITRUST)
Cherry Bekaertvijayapura, rajasthan, in Cherry Bekaert is a nationally recognized CPA firm with over 75 years of experience providing assurance, tax, and advisory services to our clients.
We are seeking a Senior Associate (HITRUST) to joi...Show moreLast updated: 17 days ago
- Promoted
Audit Associate – Canadian NGO / NPO Audits (Remote)
Scan Global Servicesvijayapura, rajasthan, inRemote
- Promoted
Escalation Manager
Palo Alto Networksvijayapura, rajasthan, in At Palo Alto Networks® everything starts and ends with our mission : .Being the cybersecurity partner of choice, protecting our digital way of life.
Our vision is a world where each day is safer and m...Show moreLast updated: 30+ days ago
- Promoted
FATCA / CRS Reporting Specialist
Optaxvijayapura, rajasthan, in Optax Limited is a small but growing advisory business that uses our bespoke software and technical expertise to simplify FATCA & CRS reporting and ensure compliance accuracy.Focusing on private fu...Show moreLast updated: 30+ days ago
- Promoted
- New!
Engineering Underwriter
RightMatch HR Services Private Limitedvijayapura, rajasthan, in The role is with a leading General Insurance Firm.Role – Engineering Underwriting.Contribute to the implementation of underwriting strategies (risk analysis, terms conditions, portfolio mix & profi...Show moreLast updated: 9 hours ago
- Promoted
Manager - Captive Insurance
Selections HR Services Private Limitedvijayapura, rajasthan, 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: 2 days ago
- Promoted
- New!
Senior Analyst / Specialist / Manager – SMART Underwriting (Casualty)
Futuristic Underwriters Pvt Ltdvijayapura, rajasthan, in About Futuristic Underwriters Pvt.We are a business transformation center dedicated to achieving efficient underwriting operations, utilizing AI / GENAI capabilities, and further advancing its digita...Show moreLast updated: 9 hours ago
- Promoted
- New!
Manager- Model Risk Management (Quants / Derivate Pricing)
Evalueservevijayapura, rajasthan, in Elevate Your Impact Through Innovation and Learning.Evalueserve is a global leader in delivering innovative and sustainable solutions to a diverse range of clients, including over 30% of Fortune 50...Show moreLast updated: 9 hours ago
- Promoted
Senior Associate- Trust and Safety Engineering
Radixvijayapura, rajasthan, in We are seeking a dedicated and analytical Senior Associate – Trust & Safety Engineer to join our Trust & Safety operations at Radix.
In this role, you will play a critical part in protecting the int...Show moreLast updated: 30+ days ago
- Promoted
Senior Manager - Risk and Compliance
Good Business Labvijayapura, rajasthan, in Good Business Lab is an independent, non-profit labor innovation company.We use rigorous academic research to prove that worker well-being programs have business impacts.
We develop market-ready, sc...Show moreLast updated: 2 days ago