This job offer is not available in your country.
Safety Aggregate Reporting Manager
IQVIA Indiamysore, karnataka, 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
Reporting Manager • mysore, karnataka, in
Related jobs
- Promoted
Validation Lead
Compliance Group IncMysore, IN We are looking for Validation Lead for Compliance Group Inc.High preference to short notice period.Develop and implement validation strategies and processes to ensure the quality and reliability of...Show moreLast updated: 30+ days ago
- Promoted
Junior Geo-Political Risk Analyst (Europe)
MAX SecurityMysore, IN MAX is Global Risk Management organization based out in Tel Aviv, Israel and its APAC HQ is based out of Mumbai.Led by veterans from Israeli Military Special Forces, Intelligence, Cyber and Secret ...Show moreLast updated: 22 days ago
- Promoted
Oracle ERP Professionals (Arabic Speaking)
TexploreIt Solutions LLCMysore, IN TexploreIt Solutions, with operations in India and the Middle East, is a rapidly growing Information Technology and consulting firm specializing in Oracle Applications, Managed Services, and integr...Show moreLast updated: 30+ days ago
- Promoted
Actuarial Life Pricing
EliteRecruitmentsMysore, 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: 20 days ago
- Promoted
Financial Risk Analyst
Green HR SolutionsMysore, IN Hiring For USA Based Multinational Company.We are seeking a detail-oriented Financial Risk Analyst to join our Risk Management team.
The ideal candidate will be responsible for identifying, analyzin...Show moreLast updated: 10 days ago
- Promoted
- New!
Regulatory Compliance Specialist
Jupiter AI LabsMysuru, Karnataka, India We are seeking a Regulatory & Compliance Specialist on a contract basis to support our compliance requirements in India and international destination countries.
This role is ideal for professionals ...Show moreLast updated: 20 hours ago
- Promoted
Regulatory Compliance Specialist -2+
Jupiter AI LabsMysore, IN Regulatory & Compliance Specialist.India and international destination countries.This role is ideal for professionals experienced in handling regulatory filings, certifications, and export-related ...Show moreLast updated: 14 days ago
- Promoted
Actuarial Life GGY AXIS
EliteRecruitmentsMysore, 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: 20 days ago
- Promoted
Service Monitoring Analyst
Art Technology and Softwaremysore, karnataka, in Service Monitoring Analysts play a key role in ensuring organization continues to exceed industry leading availability across all services (e.
Transaction Processing, webservices).Continual monitori...Show moreLast updated: 7 days ago
- Promoted
- New!
Risk Modelling Professional
beBeeCatastropheMysuru, Karnataka, India We are seeking experienced professionals to join a high-performing team within an organization focused on catastrophe modelling.
Key responsibilities include performing catastrophe and portfolio mod...Show moreLast updated: 20 hours ago
- Promoted
EHS Enablon Technical Consultants
ADR Application Development Resources, Inc.Mysore, 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: 29 days ago
- Promoted
IAM Governance Engineer - Saviynt / SailPoint
PerfictMysore, IN The IAM Senior Engineer will be responsible for the service design, build and document all key elements of the Identity Governance and Administration (IGA) infrastructure and services that are part...Show moreLast updated: 14 days ago
- Promoted
Associate Director, Safety Operations
IQVIA IndiaMysore, 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: 22 days ago
- Promoted
SAP PMO - Test Manager
delaware IndiaMysore, IN We are a renowned global corporation dedicated to delivering advanced business, IT solutions and services, assisting organizations in their business and digital transformations.Our primary goal is ...Show moreLast updated: 14 days ago
- Promoted
Senior Information Technology Audit Manager
Bahwan CyberTekMysore, IN Role : Information Technology Auditor.We are seeking a highly experienced and motivated.Information Technology Auditor.Group Internal Audit team of BCT.
This role requires a minimum of 12 years of ex...Show moreLast updated: 14 days ago
- Promoted
Causal Inference - Intern
Sony Research Indiamysore, karnataka, in Sony Research India is driving cutting-edge research and development in various locations around the globe, including laboratories in Japan, the United States, Europe, and Asia.We endeavor to creat...Show moreLast updated: 7 days ago
- Promoted
Lead Regional Compliance Specialist
Securitas GroupMysore, 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: 30+ days ago
- Promoted
Ethical Hacker
MAI LabsMysore, IN We're building something audacious, something global, in next tech at.Our mission? To distribute participatory power to billions of people in the digital economy.
What this actually means : We have b...Show moreLast updated: 14 days ago