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 solid 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.
Solid attention to detail, analytical thinking, and time management skills.
Ability to work effectively in a rapid-paced, team-oriented setting.
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.