Website:
synapmed.com
Job details:
Role:
We are looking for a Senior Drug Safety Associate to join our Pharmacovigilance team. The role involves managing regulatory safety submissions, ensuring compliance with global reporting timelines, and supporting pharmacovigilance operations.
Key Responsibilities:
- Perform electronic submission of serious and non-serious ICSRs to global regulatory authorities.
- Submit safety reports to health authorities such as USFDA, MHRA, EVC, Health Canada, and other global agencies.
- Ensure timely submission of expedited safety reports (7-day / 15-day timelines).
- Perform submission readiness checks including case completeness and regulatory reportability.
- Monitor submission queues and track acknowledgements from regulatory authorities.
- Identify and report discrepancies, delays, or system issues related to submissions.
- Coordinate with internal teams and partners as per pharmacovigilance agreements.
- Support internal and external PV audits and inspections
Requirements:
- Bachelor’s degree in Pharmacy, Nursing, or a Science-related field
- 4–6 years of Pharmacovigilance experience, preferably in regulatory submissions
- Knowledge of ICSR lifecycle, E2B(R3), and global PV regulations
Click on Apply to know more.