Pharmacovigilance Services Specialist

Sigma Allied Services; Chennai District, Bengaluru; Hybrid; INR 600,000 - 900,000; Full time

Job summary

Sigma Allied Services in India seeks a Pharmacovigilance Services Specialist to manage safety case processing end-to-end. You will review, code, enter ICSR data, and ensure compliance with global/regional PV regulations. Mandatory MBBS/MD with hands-on PV experience, MedDRA coding, and Drug Safety Operations expertise.

Willingness to work in rotational shifts and in a work-from-office setup is required. You will collaborate with internal teams to ensure timely, accurate safety case closure and

Qualifications

• MBBS/MD mandatory for this role.
• Hands-on experience in Pharmacovigilance and ICSR Case Processing.
• Strong understanding of global and regional Pharmacovigilance regulations.
• Experience in MedDRA coding and Drug Safety Operations.
• Willingness to work in rotational shifts.

Responsibilities

• Manage the affiliate mailbox and reconciliation of safety reports as per defined processes.
• Perform written follow-ups for both Serious and Non-Serious cases.
• Handle ICSR case identification, data entry, MedDRA coding, case processing, submission and follow-ups.
• Ensure ICSR processing is aligned with client guidelines and applicable global and regional Pharmacovigilance regulations.
• Support Pharmacovigilance Operations and Drug Safety Surveillance activities.
• Perform medical review and safety assessment activities as required.
• Work with internal teams and stakeholders to ensure quality and timely completion of safety cases.

Skills

Pharmacovigilance

ICSR Processing

MedDRA coding

Drug Safety Operations

Regulatory awareness

Education

MBBS / MD

Job description

Dear Candidate,

Greetings, from Sigma Allied Services,

We are hiring for Pharmacovigilance Services Specialist.

Job Title: Pharmacovigilance Services Specialist
Qualification: MBBS / MD
Location: Bangalore / Chennai
Work Mode: Work From Office
Shift: Rotational Shifts
Level: Individual Contributor

Key Responsibilities

• Manage the affiliate mailbox and reconciliation of safety reports as per defined processes.
• Perform written follow-ups for both Serious and Non-Serious cases.
• Handle ICSR case identification, data entry, MedDRA coding, case processing, submission and follow-ups.
• Ensure ICSR processing is aligned with client guidelines and applicable global and regional Pharmacovigilance regulations.
• Support Pharmacovigilance Operations and Drug Safety Surveillance activities.
• Perform medical review and safety assessment activities as required.
• Work with internal teams and stakeholders to ensure quality and timely completion of safety cases.

Key Requirements

• MBBS / MD qualification is mandatory.
• Hands-on experience in Pharmacovigilance and ICSR Case Processing.
• Good understanding of global and regional Pharmacovigilance regulations.
• Experience in MedDRA coding and Drug Safety Operations.
• Willingness to work in rotational shifts.