Are you a skilled Pharmacovigilance (PV) professional seeking to advance your career in drug safety and ICSR processing? 4C Pharma is hiring Senior Drug Safety Associates across Bangalore, Mysuru, and Hyderabad. This is a full-time work-from-office opportunity for candidates with 1โ4 years of PV experience.
If you have hands-on expertise in case intake, MedDRA coding, narrative writing, and regulatory submissions (E2B, MedWatch, CIOMS), this role offers the perfect platform to grow in the pharmaceutical and clinical research industry.
๐ Key Responsibilities
- Receive, review, and process drug safety information in compliance with regulations and SOPs.
- Perform ICSR processing: case intake, duplicate check, triage, case creation, data entry, and narrative writing.
- Conduct medical coding using MedDRA and WHO-DD.
- Ensure accurate and timely submissions to global authorities (FDA, MHRA, EudraVigilance).
- Execute literature search & safety assessment for adverse events.
- Collate safety data for PSURs, signal detection, and audits.
- Conduct quality checks (self & peer) for ICSR accuracy.
- Follow up for missing safety information with stakeholders.
- Support QMS, CAPA, deviation management, and information security policies.
๐ Qualifications
- Bachelorโs/Masterโs in Pharmacy, Life Sciences, or Biomedical Engineering.
- 1โ4 years of hands-on experience in ICSR processing.
- Proficiency in Argus Safety Database (preferred).
- Knowledge of global pharmacovigilance regulations and reporting timelines.
- Strong command of MedDRA and WHO-DD coding.
- Excellent communication, analytical, and quality focus.
- Ability to work independently and in a collaborative team environment.
๐ผ Benefits of Joining 4C Pharma
- Work with a global leader in pharmacovigilance and drug safety.
- Competitive salary package (โน4.5 โ 8 LPA depending on experience).
- Exposure to international regulatory compliance and advanced PV systems.
- Growth opportunities within the pharmaceutical and clinical research sector.
๐ฉ How to Apply
Interested candidates can send their updated resume to:
๐ง hr@4cpharma.com
๐ Locations: Bangalore | Mysuru | Hyderabad