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Drug Safety/Sr. Drug Safety Associate

2-3 years
Not Disclosed
10 May 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Drug Safety Associate

Company: Sitero

Location: Mysore

Function: Drug Safety

Job Type: Full Time, Permanent

Job Description:

Sitero, an emerging leader in Clinical services and software solutions for the life sciences industry, seeks a Senior Drug Safety Associate. The role involves assessing the safety of pharmaceutical drugs during clinical trials and post-market phases, adhering to standard guidelines and reporting findings to regulatory bodies and health authorities.

Responsibilities:

  • Analyze, review, and interpret safety data from various sources
  • Perform end-to-end case processing of individual case safety reports
  • Evaluate spontaneously reported adverse events, including those from post-marketing surveillance
  • Identify and manage duplicate/invalid Individual Case Safety Reports (ICSRs)
  • Process cases from clinical trials, literature, spontaneous sources, and social media
  • Conduct data entry into Electronic Data Capture (EDC) databases
  • Perform peer and quality reviews of cases and EDC data
  • Ensure accurate coding of events, drugs, procedures, and laboratory tests
  • Contribute to safety and pharmacovigilance training programs
  • Collaborate with Regulatory Affairs for appropriate reporting
  • Serve as a subject matter expert for vendors providing drug safety services
  • Train and mentor Pharmacovigilance associates

Qualifications:

  • Minimum 3 years of relevant experience in drug safety or clinical research
  • Degree in Life Science/Pharma or Equivalent
  • Preferably 2+ years of experience in drug safety or clinical research domain
  • Familiarity with safety databases and coding browsers (e.g., MedDRA, WHO)
  • Strong understanding of drug safety/pharmacovigilance regulations
  • Excellent organizational, documentation, and interpersonal skills
  • Good knowledge of US and EU drug safety regulations and guidelines
  • Experience with safety data collection and interpretation from clinical trials and other sources
  • Ability to build relationships, collaborate, and influence across disciplines
  • Excellent verbal, written, and presentation skills

Compensation & Benefits: Sitero offers a competitive compensation package, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.

Commitments:

  • Standard Hours: 40 hours per week, Monday – Friday, with additional hours as needed
  • Willingness to work in shifts as required

Disclaimer: Sitero is an equal opportunity employer and welcomes all job applicants. Qualified applicants will receive consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.