Senior Drug Safety Associate -ICSR Reporting & Submissions
Synapmed
- Location
- Hyderabad, Telangana, India
- Job type
- Full-time
About the role
Website:
synapmed.com
Job details:
Key Responsibilities
- Perform electronic submission of Serious and Non-Serious ICSRs to global regulatory authorities in compliance with regional reporting requirements.
- Submit safety reports to health authorities such as USFDA, MHRAUK, EVCTM, Health Canada, and other global regulatory agencies as applicable.
- Manage submissions to business partners and licensing partners as per pharmacovigilance (PV) agreements.
- Ensure timely submission of expedited reports (7-day / 15-day reporting timelines).
- Perform submission readiness checks including verification of: Case completeness, Regulatory reportability and Correct reporting timelines.
- Ensure compliance with internal SOPs, Work Instructions, and global regulatory guidelines.
- Identify and report discrepancies, delays, or system issues impacting submissions.
- Monitor submission queues and ensure cases are submitted within regulatory timelines.
- Track submission acknowledgements and follow up on regulatory gateway errors or rejection messages.
- Support team/organization during internal or external audits and inspections locally and globally for PV.
- Conduct PV training for company personnel as necessary.
- All the respective pharmacovigilance activities delegated by your reporting manager.
Preferred Background
- 3–6 years of experience in Pharmacovigilance, with at least 2–3 years in regulatory submissions.
- Strong knowledge of global pharmacovigilance regulations and reporting timelines.
- Bachelor’s degree in pharmacy, nursing or a science-related field and previous Pharmacovigilance background preferred.
Skills Required
- Strong understanding of ICSR submission and regulatory reporting requirements
- Experience with E2B(R3) electronic submission.
- Knowledge of regulatory reporting timelines (7/15-day reporting)
- Attention to detail and compliance orientation
- Ability to manage high submission volumes under strict timelines
- Strong communication and coordination skills
- Proficiency in pharmacovigilance safety databases and regulatory gateways
Click on Apply to know more.
This page is fully interactive when JavaScript is enabled. Please enable JavaScript to apply or browse related roles.