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Senior Drug Safety Associate

2+ years
Not Disclosed
10 Dec. 18, 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 Title: Senior Drug Safety Associate
Location: India

Job Description:

We are looking for a Senior Drug Safety Associate to ensure the complete and accurate case processing of adverse event reports. This position involves following company SOPs, internal business practices, and regulatory guidance to ensure compliance with worldwide safety regulations.

Minimum Qualifications & Experience:

  • Experience: 4-6 years of pharmaceutical or CRO experience, with a focus on safety-related areas in clinical trials.
  • Skills:
    • Knowledge of clinical trials and pharmacovigilance requirements.
    • Experience in international drug safety regulatory reporting obligations and compliance.
    • Proficient in coding medical terminologies, case processing, and safety report submission.
    • Thorough understanding of medical terminology and summarizing medical information.
    • Strong computer proficiency and ability to work in specific databases.
    • Experience following guidelines, procedural documents, and SOPs.
    • Fluent in written and spoken English.
    • Excellent interpersonal skills and the ability to communicate professionally at all levels.
    • Strong time management and multitasking capabilities.

Why Novotech?

Novotech is committed to creating an inclusive work environment, offering flexible working options, paid parental leave, wellness programs, and development opportunities. We are proud to be an employer of choice for gender equality and diversity, welcoming individuals of all backgrounds, including LGBTIQ+, those with disabilities, and those with caregiving responsibilities. We are a Circle Back Initiative Employer and are committed to responding to every application.