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 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.