06 Aug
|
Orcapod Consulting Services
|
Hyderabad
06 Aug
Orcapod Consulting Services
Hyderabad
Job Description Safety Processing Executive (SPE) Pharmacovigilance
Job Title: Safety Processing Executive (SPE) Pharmacovigilance
Experience: 1–2 Years
Location: Mumbai / Pune / Hyderabad / Bangalore
Work Mode: Work From Office (WFO)
Shift Timings:
- 7:00 AM – 4:00 PM
- 4:00 PM – 1:00 AM
Notice Period: Immediate to 60 Days
Educational Qualification
- B.Pharm or M.Pharm (Mandatory)
Roles & Responsibilities
- Perform end-to-end processing of Individual Case Safety Reports (ICSRs) in accordance with global regulatory requirements and company SOPs.
- Review, assess, and accurately enter adverse event information into Pharmacovigilance safety databases.
- Ensure timely and high-quality case processing while meeting productivity and quality targets.
- Code adverse events, medications, and medical history using MedDRA and WHO Drug Dictionary, where applicable.
- Follow Pharmacovigilance guidelines and maintain compliance with regulatory requirements.
- Collaborate with cross-functional teams to resolve case-related queries and support workflow activities.
- Maintain confidentiality and data integrity while handling patient safety information.
Required Skills
- 1–2 years of experience in Pharmacovigilance Safety Case Processing.
- Hands-on experience with Veeva Safety and/or Argus Safety database.
- Good understanding of ICSR processing and Pharmacovigilance workflows.
- Knowledge of global Pharmacovigilance regulations and GVP principles is preferred.
- Solid attention to detail and analytical skills.
- Excellent written and verbal communication skills in English.
Preferred Candidates
- Candidates from organizations such as TCS, Accenture, Parexel, or other Pharmaceutical, CRO, or Life Sciences companies with relevant Pharmacovigilance experience.
If you have the required Pharmacovigilance experience and are looking to grow your career in drug safety, we'd love to hear from you.
📌 Pharmacovigilance Specialist (Hyderabad)
🏢 Orcapod Consulting Services
📍 Hyderabad