Safety Writer - Aggregate Reporting (Ar)

Advity Research

3-5 years

Not Disclosed

Hyderabad India

10 Feb. 10, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Department: Pharmacovigilance

Qualification:

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

Mode of Work:

On-premise

Job Description:

Aggregate Reports Management:
- Serve as Advity’s primary contact and subject matter expert for aggregate reports.
- Draft, retrieve, and analyze safety data from global safety databases for inclusion in Aggregate Reports (PADER, PSUR, PEBRER, RMP, DSUR, AdCo’s).
- Ensure comprehensive and consistent aggregate analysis to establish the risk-benefit profile of products in compliance with Health Authority (HA) requirements.
Cross-functional Communication & Coordination:
- Effectively interact and communicate internally and cross-functionally in a matrixed environment.
- Alert Medical Safety Physicians regarding potential safety issues and support them in monitoring product safety profiles.
Quality Control & Compliance:
- Conduct independent QC of Aggregate Reports to ensure completeness, consistency, and regulatory compliance.
- Adhere to good documentation practices for audit and inspection readiness.
Operational Excellence & Process Improvement:
- Support projects related to operational excellence, including testing of safety systems and IT applications.
- Contribute to process improvements driven by internal and external requirements.
Pharmacovigilance & Safety Monitoring:
- Review literature articles to identify case safety reports.
- Perform operational Pharmacovigilance activities for assigned developmental and marketed products.
- Assist in signal generation and safety analysis activities.
Regulatory & Compliance Activities:
- Support Health Authority inspections and audits.
- Assist in developing Corrective & Preventive Actions (CAPA) to address safety findings.
- Stay updated with current global Pharmacovigilance regulatory requirements.

This role requires strong analytical skills, regulatory knowledge, and the ability to collaborate effectively across teams to ensure product safety and compliance.

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Safety Writer - Aggregate Reporting (Ar)

Job Description

Department: Pharmacovigilance

Qualification:

Mode of Work:

Job Description:

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