Drug Safety Associate Ii - Psur Report Authoring And Review

2-6 years

Not Disclosed

India

10 July 26, 2024

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, 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

Job Title: PSUR Specialist

Key Responsibilities:

Authoring and Reviewing PSURs:
- Prepare and review Periodic Safety Update Reports (PSURs/PBRERs) for submission to health authorities.
- Ensure the accuracy, completeness, and regulatory compliance of all PSURs.
Literature Search and Validation:
- Conduct literature searches to gather relevant data for PSUR preparation.
- Validate information from literature searches to ensure its accuracy.
Data Management:
- Extract and validate data from various sources, including Reference Safety Information (RSI), sales data, previous reports, and Risk Management Plans (RMP).
- Generate Line Listings (LL) from the safety database for inclusion in PSURs.
Process Management:
- Manage and reconcile relevant process trackers to ensure all activities are documented and on schedule.
- Provide reliable support for high-priority ad-hoc activities related to PSUR preparation.
Client Interaction:
- Communicate with client personnel to resolve issues related to PSURs, ensuring adherence to client policies.
- Ensure PSUR deliverables comply with regulatory requirements and are submitted within agreed timelines.
Subject Matter Expertise and Training:
- Serve as a subject matter expert (SME) for PSUR preparation and review.
- Provide training and mentoring to team members on PSUR-related processes and regulatory requirements.

Qualifications:

Bachelor’s degree in a relevant scientific or medical field (e.g., Pharmacology, Medicine, Life Sciences). Advanced degree preferred.
Experience in pharmacovigilance, drug safety, or a related field, with a focus on PSUR preparation and review.
Knowledge of regulatory requirements for PSURs/PBRERs.
Strong analytical and problem-solving skills with the ability to evaluate and interpret complex safety data.
Excellent written and verbal communication skills.
Proficiency in safety databases and data extraction/validation processes.
Strong organizational skills with the ability to manage multiple tasks and projects simultaneously.
Demonstrated ability to collaborate effectively with cross-functional teams and provide expert guidance.

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Drug Safety Associate Ii - Psur Report Authoring And Review

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