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Senior Drug Safety Associate

Novotech
NovoTech
4-6 years
Not Disclosed
10 Dec. 6, 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

Senior Drug Safety Associate
Location: India

Brief Position Description:
Responsible for accurate case processing of adverse event reports following SOPs, business practices, and regulatory guidelines to ensure compliance with global safety regulations.

Minimum Qualifications & Experience:

  • Experience: 4-6 years in pharmaceutical/CRO focusing on safety in clinical trials.
  • Skills: Knowledge of clinical trials, pharmacovigilance, regulatory reporting, medical terminology, case processing, and safety reporting.
  • Technical: Proficient in databases, SOPs, and compliance guidelines.
  • Language: Fluent in written and oral English.
  • Interpersonal Skills: Professional communication, time management, multitasking.

Responsibilities:

  • Process and manage adverse event cases adhering to compliance requirements.
  • Handle medical coding, safety report submissions, and case summaries.
  • Work with SOPs and follow procedural documents.
  • Communicate effectively across organizational levels.

About Novotech:
A leading employer offering flexible work options, parental leave, wellness programs, and professional development opportunities. Committed to diversity and inclusion, Novotech supports gender equality, LGBTIQ+ individuals, and those with disabilities or caring responsibilities.

Novotech is a Circle Back Initiative Employer, ensuring every applicant receives a response.