No longer accepting applications
Safety Aggregate Reporting Manager
IQVIA Indiaindore, India8 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 • indore, India
Related jobs
- Promoted
Business Risk Manager (Technology)
Revolutindore, India 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: 4 days ago
- Promoted
Lead Regional Compliance Specialist
Securitas Groupindore, India 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: 8 days ago
- Promoted
Group Reporting Analyst
Tagindore, India The Group Reporting Analyst will be part of Tag’s Group Reporting Team, responsible for delivery of robust, accurate and timely financial reporting, budget, forecast and cashflow reporting.The team...Show moreLast updated: 8 days ago
- Promoted
Manager- SACCR / Counterparty Credit Risk
Evalueserveindore, India 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: 6 days ago
- Promoted
Associate Solutions Manager
ElucidataIndore, Madhya Pradesh, India Associate Solution Manager Function : .Delhi / Bangalore (3 days in office).About the Company : Elucidata is a TechBio Company headquartered in San Francisco.
Our mission is to unleash personalized medic...Show moreLast updated: 1 day ago
- Promoted
Escalation Manager
Palo Alto Networksindore, India 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: 6 days ago
- Promoted
Safety Officer
ConfidentialPithampur, Indore Issuance of work permit on daily basis.Provide training to contractors, employees and visitors with respect to EHS.Conducting periodic mock drills at site.
Provide appropriate PPE and ensure its cor...Show moreLast updated: 27 days ago
- Promoted
Underwriter
WNSindore, India The Mortgage underwriting associate evaluate and determine the eligibility of loan applications of residential mortgage 1 to 4 family loans.
Mortgage underwriting associate role includes but not lim...Show moreLast updated: 8 days ago
- Promoted
Accounting & Reporting Specialist
Scalemetricsindore, India Scalemetrics is a leading provider of modular CFO services, dedicated to supporting startups and SMEs in scaling their businesses globally.
Mission : Enhance business predictability and value through...Show moreLast updated: 8 days ago
- Promoted
Audit Operations Manager
ConfidentialIndore, India 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
Account Manager
DemandXindore, India Excellent English written and verbal communication.Strong computer skills and learning aptitude.Exceptional attention to detail (99% accuracy standard).
Availability during US business hours.Prior e...Show moreLast updated: 8 days ago
- Promoted
Program Associate
1Learn AIindore, madhya pradesh, in We’re looking for a sharp generalist who can lead across operations, product, growth, and execution.You’ll own critical projects end-to-end, turn ideas into outcomes, and build systems that keep th...Show moreLast updated: 30+ days ago
- Promoted
Regulatory / Quality Assurance (Senior Executive / Associate Manager)
Merlin MD Pte Ltdindore, India Tips : Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.
Participate in the implementation and maintenance of the managemen...Show moreLast updated: 4 days ago
- Promoted
Financial Reporting & Analytics Associate
FEXLE Services Private Limitedindore, India Role Name : Financial Reporting & Analytics Associate.Experience : 5-10 Years of Experience.FEXLE- A Xoriant Company is a rapidly growing Salesforce consulting and development company with a strong t...Show moreLast updated: 4 days ago
- Promoted
Revenue Operations Associate
Scrut Automationindore, India Job Title : Revenue Operations Associate.Scrut Automation is a global leader in Governance, Risk, and Compliance (GRC).Our mission is to help modern enterprises move beyond simple checklists to buil...Show moreLast updated: 8 days ago
- Promoted
Escalation Manager
TNV Methodindore, India TNV Method by Tanvi Parikh Fitness is a global fitness platform.We combine lifestyle management solutions (Nutrition, Mindset, Exercise and more) with personlized coaching to help our customers tra...Show moreLast updated: 8 days ago
- Promoted
Audit Manager- Healthcare
Citrin Cooperman India LLPindore, India 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: 8 days ago
- Promoted
Quality Assurance Manager
INFOCRATSIndore, India We are looking for an experienced QA Manager to lead our Quality Assurance team.The ideal candidate will excel in manual and automation testing for web and mobile applications, mentor QA teams, imp...Show moreLast updated: 30+ days ago