Drug Safety Associate

2+ years

Not Disclosed

Bangalore

10 Oct. 14, 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, 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

Job Summary: Drug Safety Associate

Position Overview: The Drug Safety Associate will ensure the accurate and complete processing of adverse event reports in accordance with company standard operating procedures (SOPs), internal practices, and regulatory guidance. This role is crucial for maintaining compliance with global safety regulations.

Minimum Qualifications & Experience:

A registered nurse, pharmacist, or holder of a health/biomedical degree or other related scientific qualification.
A minimum of 2 years of safety-related experience in a pharmaceutical company or CRO.
At least 2 years in a Drug Safety Associate role at Novotech, demonstrating a solid understanding of processes and readiness for increased responsibilities.
Expertise in international drug safety regulatory reporting, end-to-end case processing, client communication, and data reconciliation.
Proficient knowledge of medical terminology and the ability to write clear, concise medical texts.
Ability to learn about various disease and therapeutic areas.
Fluency in English, with the ability to independently evaluate data and follow guidelines and procedural documents.

Key Responsibilities:

Manage drug safety reporting for Novotech, including configuring and reviewing safety databases with study-specific information.
Prepare and review study-specific safety management plans and related tools per client requirements.
Complete full case information in the database, ensuring quality review for accuracy and completeness.
Liaise with medical monitors, clients, and study teams to clarify information for case processing.
Prioritize data entry activities based on receipt dates in compliance with SOPs.
Process adverse event reports and maintain the safety database, preparing reports for regulatory authorities.
Ensure timely submission of reports to regulatory agencies and respond promptly to inquiries.
Participate in project teams, inspections, and audit readiness activities.
Conduct literature searches and monitor for adverse event reports.
Support the continuous development of personal and team skills, including mentoring junior staff.
Act as a subject matter expert on expedited ICSR and periodic reports (DSUR/PSUR/PBRER).

Company Culture: At Novotech, we pride ourselves on being an employer of choice, committed to gender equality and inclusivity. We offer flexible working options, paid parental leave for both parents, wellness programs, and ongoing development opportunities. We actively seek passionate individuals, including those who identify as LGBTIQ+, have disabilities, or caregiving responsibilities. As a Circle Back Initiative Employer, we promise to respond to every application.

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Drug Safety Associate

Job Description

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