Pharmacovigilance Associate

Orcapod Consulting Services; Navi Mumbai; On-site; INR 350,000 - 550,000; Full time

Job summary

Orcapod Consulting Services in Mumbai/Bangalore is seeking a detail-oriented Senior Process Executive (SPE) with 1–2 years of Pharmacovigilance experience. You will handle end-to-end ICSR processing and work with Veeva Safety and Oracle Argus Safety to ensure regulatory compliance.

The role requires knowledge of PV regulations and strong written and verbal English communication, with flexibility for rotating shifts in a fast-paced team environment.

Qualifications

• 1–2 years hands-on experience in Pharmacovigilance safety case processing.
• Experience using Veeva Safety and/or Oracle Argus Safety databases.
• Good understanding of ICSR processing and Pharmacovigilance workflows.
• Knowledge of global Pharmacovigilance regulations and GVP guidelines.

Responsibilities

• Perform end-to-end processing of Individual Case Safety Reports (ICSRs) in compliance with global regulatory requirements and internal SOPs.
• Review and assess adverse event reports for completeness, accuracy, and regulatory compliance.
• Perform case triage, data entry, medical coding, case assessment, narrative writing, and follow-up activities.
• Process cases within established timelines while maintaining quality and productivity targets.
• Work with Pharmacovigilance safety databases, including Veeva Safety and Oracle Argus Safety.
• Identify and resolve data discrepancies to ensure high-quality case processing.
• Collaborate with internal teams to support operational efficiency and continuous process improvement.
• Maintain compliance with applicable Pharmacovigilance regulations, GVP guidelines, and company quality standards.

Skills

Pharmacovigilance

ICSR processing

Regulatory compliance

English communication

Time management

Education

B.Pharm

M.Pharm

Degree from a recognized university

Tools

Veeva Safety

Oracle Argus Safety

Job description

Job Description Senior Process Executive (SPE) – Pharmacovigilance

Position

Senior Process Executive (SPE) – Pharmacovigilance

Location

Mumbai | Bangalore

Experience

1–2 Years

Qualification

• B.Pharm or M.Pharm
• Degree from a recognized university

Employment Type

Full-time

Work Mode

Work From Office (WFO)

Shift Timings

• 7:00 AM – 4:00 PM
• 4:00 PM – 1:00 AM
  (Candidates should be flexible to work in rotational shifts.)

Job Summary

We are looking for a detail-oriented and motivated Senior Process Executive (SPE) with 1–2 years of experience in Pharmacovigilance safety case processing. The ideal candidate will have hands‑on experience with Pharmacovigilance safety databases such as Veeva Safety and Oracle Argus Safety and a strong understanding of end-to-end Individual Case Safety Report (ICSR) processing.

Key Responsibilities

• Perform end-to-end processing of Individual Case Safety Reports (ICSRs) in compliance with global regulatory requirements and internal SOPs.
• Review and assess adverse event reports for completeness, accuracy, and regulatory compliance.
• Perform case triage, data entry, medical coding, case assessment, narrative writing, and follow-up activities.
• Process cases within established timelines while maintaining quality and productivity targets.
• Work with Pharmacovigilance safety databases, including Veeva Safety and Oracle Argus Safety.
• Identify and resolve data discrepancies to ensure high-quality case processing.
• Collaborate with internal
• teams to support operational efficiency and continuous process improvement.
• Maintain compliance with applicable Pharmacovigilance regulations, GVP guidelines, and company quality standards.

Required Skills

• 1–2 years of hands-on experience in Pharmacovigilance safety case processing.
• Experience using Veeva Safety and/or Oracle Argus Safety databases.
• Good understanding of ICSR processing and Pharmacovigilance workflows.
• Knowledge of global Pharmacovigilance regulations and GVP guidelines.
• Excellent written and verbal communication skills in English.
• Strong attention to detail, analytical thinking, and time management skills.
• Ability to work effectively in a fast-paced, team-oriented environment.

Preferred Profile

• Candidates with experience in organizations such as TCS, Accenture, Parexel, or other leading Pharmacovigilance/life sciences companies.
• Candidates available to join within 0–60 days will be preferred.