Safety Writer-Aggregate Reporting(AR)

☞ Novartis India

Ver: 107

Dia de atualização: 06-05-2024

Localização: Hyderabad / Secunderabad Telangana

Categoria: R & D Ciência Outro

Indústria: Pharmaceuticals

Posição: Associate

Tipo de empregos: Full-time

Salário: View Detail

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Conteúdo do emprego

Job Description

2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety.

Your responsibilities include, but are not limited to:
  • Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing, and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations.
  • Ensures accurate receipt, maintenance, and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
  • To support management of operational processes in ensuring compliance with Novartis global/local procedures, national and international regulations/standards/guidelines for pharmacovigilance of Novartis marketed and investigational products
  • Manage collection, processing, documentation, reporting and follow-up of all adverse events (AE) reports for all Novartis products from clinical trials, post-marketing studies (PMS), Patient Oriented Programs (POP), registries and all Spontaneous Reports (SR).
  • Transcribe, translate (where required) and enter data of all Serious Adverse Events (from Clinical Trials,) and all adverse events (from POPs, PMS, registries and all SRs) from source documents onto safety systems accurately and consistently with emphasis on timeliness and quality.
  • Record and track receipts, submissions and distributions of documents like SAEs, SRs, Investigator Notifications etc in cooperation with other departments -Manage reporting/submission/distribution of safety reports/updates/information to Local Health Authorities and/or clinical operations in cooperation with other Departments. Work with other local/global PV associates to ensure accurate evaluation of safety data.
  • Interact and exchange relevant safety information with LHA, PV associates, other functional groups, and third-party contractor, if applicable. -Survey and monitor global/ regional/national (as applicable) pharmacovigilance regulations and provide update to global PVO organization. -Develop, update, and implement local procedures to ensure compliance with PVO global procedures and national requirements. -Management and maintenance all relevant assigned PVO databases, if applicable.
  • Develop and update training materials for pharmacovigilance. Ensure support for and close-out of audits, corrective action plan activities and Health Authority inspections. Provide timely, relevant information to trial coordinators, CRAs and other Novartis staff
Minimum Requirements
  • Operations Management and Execution
  • Collaborating across boundaries Functional Breadth
  • Global Regulatory compliance to world-wide Health Authorities and external partners for AR Quality of support to health authority inspections and audits
Why consider Novartis?

799 million. That’s how many lives our products touch. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Novartis. Join us and help us reimagine medicine.

Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.

Division
Global Drug Development

Business Unit
CMO & PATIENT SAFETY GDD

Country
India

Work Location
Hyderabad, AP

Company/Legal Entity

Nov Hltcr Shared Services Ind

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No
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Data limite: 20-06-2024

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