This job offer is not available in your country.
High Salary! Safety Aggregate Reporting Manager
IQVIA IndiaMumbai, Maharashtra, India21 hours 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
High Salary Manager • Mumbai, Maharashtra, India
Related jobs
)
- Promoted
Finance Review Manager
CoatsKalyan-Dombivli, 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: 28 days ago
- Promoted
Quality Assurance Supervisor
CaldicRaigad, Maharashtra, India Work Location : Caldic Specialties India Private Limited.B-06-E, ESR TALOJA Industrial & Logistics Park,.Village Usatane, Khoni Taloja Road, Taluka Ambernath, District Thane & Village Nitlas, Taluka...Show moreLast updated: 3 days ago
- Promoted
Associate Director, Safety Operations
IQVIA IndiaMumbai, 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: 12 days ago
- Promoted
Ecommerce Reporting and Analytics Lead
MultiplyMiiThane, 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: 12 days ago
- Promoted
Actuarial Life Pricing
EliteRecruitmentsKalyan-Dombivli, 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: 10 days ago
- Promoted
Sales Manager – Real Estate
Reflex Realty LLPTardeo, Maharashtra, India Lead the Future of Real Estate with Reflex Projects LLP!.As we expand our portfolio of luxury developments, we’re on the lookout for a.
If you have a passion for real estate, a proven track record i...Show moreLast updated: 30+ days ago
- Promoted
Assistant Manager- Safety & Administration
Asahi India Glass Limited (AIS)Navi Mumbai, Maharashtra, India Responsible for identifying hazards in the premises and provide Safety training to all employees to avoid any accidents while on job.
Thereby achieve company's goal of Safety first.Take care of gene...Show moreLast updated: 19 days ago
- Promoted
Chief Manager (HR)
Universal Ai UniversityKarjat, Maharashtra, India To assist in the planning, implementation, and administration of Human Resource functions including recruitment, personnel administration, service matters, HR policy compliance, and employee welfar...Show moreLast updated: 30+ days ago
- Promoted
Director Environment Health Safety
Quaker HoughtonMumbai, 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: 12 days ago
- Promoted
Lead Regional Compliance Specialist
Securitas GroupKalyan-Dombivli, 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
Financial Reporting (CA)
LTIMindtreeThane, 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: 21 days ago
- Promoted
- New!
Safety Aggregate Reporting Manager (Only 24h Left)
IQVIA IndiaMumbai, Maharashtra, India 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 app...Show moreLast updated: 1 hour ago
- Promoted
Reporting Specialist
Hogarth Studios IndiaKalyan-Dombivli, 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: 12 days ago
- Promoted
Actuarial Life GGY AXIS
EliteRecruitmentsThane, 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: 10 days ago
- Promoted
Customer Success Associate
BHIVE WorkspaceBandra, Maharashtra, India We are seeking a motivated and detail-oriented.This is an excellent opportunity for a fresh graduate to gain hands-on experience in client relationship management, customer engagement, and retentio...Show moreLast updated: 3 days ago
- Promoted
Safety Aggregate Reporting Manager
IQVIA IndiaMumbai, Maharashtra, India Designation : Safety Aggregate Reporting Manager.Skill : Authoring Aggregate reports.Act as a stand-alone global functional lead at a project level applying experience, knowledge and expertise for S...Show moreLast updated: 30+ days ago
- Promoted
- New!
Environment, Health and Safety Manager
Menschen Consulting Pvt. Ltd.Mumbai, Maharashtra, India To lead and ensure effective implementation of Environment and Social (E&S) safeguards across all phases of the infrastructure project, in compliance with national regulations and international sta...Show moreLast updated: less than 1 hour ago
- Promoted
Senior Associate- Trust and Safety Engineering
RadixMumbai, Maharashtra, India 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