Drug Safety/Sr. Drug Safety Associate

2-3 years

Not Disclosed

Mysore

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.

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Drug Safety/Sr. Drug Safety Associate

Job Description

Job Title: Senior Drug Safety Associate

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