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Safety Writer – Aggregate Reporting (Ar)

3-5 years
Not Disclosed
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Here’s the Pharmacovigilance - Aggregate Reporting Expert job description:


Department

Pharmacovigilance


Qualification

  • Graduate/Post Graduate/Doctorate degree in Life Sciences, Pharmacy, Medical Sciences, or an equivalent degree.
  • Fluency in English.

Mode of Work

  • On-premise

Job Description

1. Primary Contact for Aggregate Reports

  • Serve as Advity’s primary contact and expert for aggregate reports such as PADER, PSUR, PEBRER, RMP, DSUR, and ADCO.
  • Interact and communicate effectively both internally and cross-functionally in a highly matrixed environment.

2. Safety Data Retrieval and Analysis

  • Draft, retrieve, and analyze safety data from the global safety database.
  • Ensure that the safety data is presented adequately in aggregate reports (e.g., PADER/PSUR/PEBRER/RMP/DSUR/ADCO).

3. Risk-Benefit Profile Assessment

  • Perform a comprehensive and consistent aggregate analysis to establish the risk-benefit profile of the product that meets all Health Authority (HA) requirements.

4. Alert and Monitor Safety Issues

  • Alert Medical Safety Physicians of potential safety issues.
  • Assist in monitoring the safety profile of products.

5. Quality Control and Documentation

  • Support independent QC of aggregate reports to ensure the information is complete, consistent, and compliant with both regulatory and Advity standards.
  • Adhere to good documentation practices to ensure audit/inspection readiness.

6. Operational Excellence & Process Improvements

  • Support projects related to operational excellence, including testing of safety systems and IT applications.
  • Drive process improvements according to internal and external drivers.

7. Literature Review & Case Safety Reports

  • Review literature articles to identify case safety reports.

8. Operational Pharmacovigilance Activities

  • Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products.

9. Signal Generation & Safety Analysis

  • Assist in signal generation and safety analysis activities.

10. Regulatory Compliance & Audits

  • Support Health Authority inspections and audits.
  • Help develop Corrective & Preventative Actions (CAPA) to address safety findings.

11. Stay Informed on Regulatory Requirements

  • Responsible for staying informed about current global pharmacovigilance regulatory requirements.

This role is integral to ensuring the safety and regulatory compliance of Advity’s products, overseeing critical safety data, and interacting with key stakeholders across teams. Let me know if you'd like to make further modifications or add specific details!