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Senior Drug Safety Associate

4-6 years
Not Disclosed
10 Dec. 20, 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
Company: Novotech

Position Overview:
The Senior Drug Safety Associate is responsible for the complete and accurate processing of adverse event reports in compliance with company standard operating procedures, internal practices, and regulatory guidelines. This position ensures adherence to global safety regulations within the pharmaceutical and clinical trial environment.

Minimum Qualifications & Experience:

  • 4 to 6 years of experience in the pharmaceutical or CRO industry with a focus on safety-related areas in clinical trials.
  • Strong understanding of clinical trials and pharmacovigilance requirements.
  • Proficiency in international drug safety regulatory reporting obligations and compliance.
  • Experience in coding medical terminologies, case processing, and safety report submissions.
  • Knowledge of medical terminology with the ability to summarize complex medical information.
  • Strong computer skills and proficiency in using relevant databases.
  • Ability to adhere to guidelines, SOPs, and procedural documents.
  • Fluent in both written and spoken English.
  • Good interpersonal and communication skills for interaction with all levels of the organization.
  • Strong time management and multitasking abilities.

Why Novotech?
Novotech offers a supportive and inclusive workplace where diversity is celebrated. We are committed to gender equality and providing flexible work options. We provide our employees with benefits such as paid parental leave for both parents, flexible leave entitlements, wellness programs, and continuous development opportunities.

We welcome applications from individuals of all backgrounds, including those who identify as LGBTIQ+, have disabilities, or have caring responsibilities.

Commitment to Diversity:
Novotech is proud to be a Circle Back Initiative Employer. We commit to responding to every application and encourage individuals from diverse backgrounds to apply.