Job Overview:

Responsible for end-to-end pharmacovigilance case processing, follow-up, MedDRA coding, narrative writing, quality control, and regulatory submissions in compliance with SOPs and GVP requirements.

Ensures timely, accurate, and compliant case management while supporting regulatory reporting, stakeholder communication, and mentoring of junior PV team members.

Key Responsibilities:
- Process serious and non-serious cases within LSMV or Argus in line with SOPs.
- Process literature cases within LSMV or Argus in line with SOPs.
- Carry out MedDRA coding and narrative writing to a high standard.
- Mentor and support junior PV Scientists and associates.
- Ensure GVP compliance and quality across all activities.
- Generate and issue follow-up queries to relevant sources.
- Perform source data reconciliation to ensure case completeness and accuracy.
- Manage cases through the follow-up lifecycle within compliance timelines.
- Communicate effectively with reporters, affiliates, and internal teams.




- Maintain accurate follow-up tracking and records.
- Support quality and compliance in all follow-up activities.
- Escalate outstanding or overdue follow-ups appropriately
- Ensure submissions comply with applicable regulatory requirements, including FDA, EMA, MHRA, PMDA, Health Canada, and other health authorities
- Maintain accurate documentation, submission records, and audit trails
- Monitor submission timelines and ensure compliance with reporting requirements for responsible, unexpected, and reportable adverse events.
- Perform quality control checks on case data, narratives, MedDRA coding, and submission documentation
- Record and review adverse drug reactions in the safety database or other database, as relevant, for post marketing and clinical trial reports in accordance with the applicable regulatory standards and clients’ procedures, with high accuracy and quality.

📌 Senior Associate (Mumbai)
🏢 Soterius
📍 Mumbai