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Senior Drug Safety Associate

1-2 years
₹5.5 LPA – ₹8.5 LPA
10 Aug. 5, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Senior Drug Safety Associate – MICC (Night Shift)
Location: Hyderabad, India
Experience: 1–2 years (Minimum); 2–4 years (Preferred in Drug Safety, Clinical Research, or MICC)
Employment Type: Full Time | Night Shift

Estimated Salary: ₹5.5 LPA – ₹8.5 LPA (based on experience and industry standards in Hyderabad)


Role Overview:

As a Senior Drug Safety Associate – MICC, you will be an integral member of the Medical Information Contact Center (MICC), responsible for delivering accurate, timely, and scientifically balanced responses to inquiries from healthcare professionals, consumers, and external stakeholders. This role involves handling medical information, pharmacovigilance, product quality complaints, and call quality reviews, while ensuring full compliance with regulatory standards and client expectations.


Key Responsibilities:

Call Quality and Compliance:

  • Perform Quality Control (QC) of calls as per client protocols.

  • Review recorded calls involving Adverse Events (AEs), Product Quality Complaints (PQCs), and Medical Information (MI).

  • Validate accuracy of information provided based on approved Reference Safety Information (RSI), FAQs, and other relevant resources.

  • Ensure consistency and completeness across:

    • Call recordings

    • Source documents

    • Telephone Contact Forms (TCFs)

    • MICC/Safety databases

  • Make necessary corrections in TCFs, MICC database, or Safety Book-in forms if discrepancies are found.

  • Monitor voicemail inbox and assign voicemails to call handlers promptly.

Medical Information Support:

  • Act as a fully functional MICC specialist.

  • Respond to unsolicited medical/safety queries from HCPs and consumers via phone, email, fax, or web.

  • Handle inquiries related to MI, PQCs, AEs, or a combination of these, following client SOPs and regulatory guidance.

  • Document and report:

    • Adverse events

    • Pregnancy and special situation reports

    • Product quality complaints

  • Use client-approved data (labeling, literature, internal data) to provide accurate and regulatory-compliant responses.

  • Prepare custom responses as required using medical/scientific sources.


Candidate Profile:

Educational Requirements:

  • Bachelor’s degree in Pharmacy, Healthcare, or Life Sciences (mandatory)

Preferred Skills & Experience:

  • 2–4 years of experience in Drug Safety, Clinical Research, or Medical Information roles.

  • Solid understanding of medical terminology, pharmacovigilance, and regulatory compliance.

  • Proficiency in tools like:

    • Microsoft Office Suite

    • Salesforce, IRMS, Veeva Vault, or similar medical information systems.

  • Strong written and verbal communication skills.

  • Detail-oriented with high standards of documentation accuracy.

  • Ability to multitask effectively in a high-pressure, regulated environment.


Join a team that values patient safety, scientific integrity, and compliance. If you're driven to make a difference in the world of drug safety and enjoy night shift dynamics, this opportunity is for you.