Senior Associate - Clinical Safety & Pharmacovigilance
soterius· Clinical Safety & Pharmacovigilance
About this role
Job Description: Submission - Senior Associate
Department: Pharmacovigilance / Drug Safety
Job Summary
The Pharmacovigilance Submission Associate (ICSR) is responsible for the preparation, quality review, and timely electronic/manual submission of Individual Case Safety Reports (ICSRs) to regulatory authorities, partners, and clients in compliance with global pharmacovigilance regulations and company procedures. The role supports patient safety by ensuring accurate and compliant safety reporting within regulatory
timelines.
Key Responsibilities
- Prepare and submit expedited and non-expedited ICSRs to global regulatory authorities and business partners.
- Ensure submissions comply with applicable regulatory requirements, including FDA, EMA, MHRA, PMDA, Health Canada, and other health authorities.
- Perform quality control checks on case data, narratives, MedDRA coding, and submission documentation.
- Generate and transmit E2B(R3) electronic reports through safety databases and reporting gateways.
- Monitor submission timelines and ensure compliance with reporting requirements for serious, unexpected, and reportable adverse events.
- Track acknowledgment receipts, submission statuses, and reconciliation activities.
- Coordinate with case processing, medical review, quality assurance, and regulatory aairs teams to resolve case-related queries.
- Maintain accurate documentation, submission records, and audit trails.
- Support health authority inspections and internal audits by providing required submission documentation.
- Participate in process improvement initiatives and SOP reviews to enhance submission quality and efficiency.
Required Qualifications
- Bachelor's or master's degree in pharmacy.
- 4-5 years of experience in Pharmacovigilance, Drug Safety, or ICSR submission activities.
- Understanding of global pharmacovigilance regulations and reporting requirements.
- Experience with safety databases such as Oracle Argus Safety, Aris Global LifeSphere, or similar PV systems.
Required Skills
- Strong knowledge of ICSR lifecycle and regulatory reporting timelines.
- Familiarity with E2B(R2)/E2B(R3) submission standards.
- Knowledge of MedDRA and WHO Drug coding concepts.
- Excellent attention to detail and data quality focus.
- Strong organizational and time management skills.
- Ability to manage multiple submissions within stringent regulatory deadlines.
- Effective written and verbal communication skills.
- Proficiency in Microsoft Oice applications, particularly Excel and Word
Preferred Skills
- Experience with gateway submissions and health authority portals.
- Knowledge of ICH E2A, E2B, E2D, GVP Modules, and FDA safety reporting requirements.
- Experience in reconciliation activities and submission troubleshooting.
- Understanding of PV compliance metrics and reporting.
Frequently Asked Questions
Is the salary disclosed for the Senior Associate - Clinical Safety & Pharmacovigilance position at soterius?
The salary for this Senior Associate - Clinical Safety & Pharmacovigilance role at soterius is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Senior Associate - Clinical Safety & Pharmacovigilance position at soterius located?
This Senior Associate - Clinical Safety & Pharmacovigilance role at soterius is based in Noida, UP, India. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Senior Associate - Clinical Safety & Pharmacovigilance role at soterius full-time or part-time?
This is listed as a FULL TIME position. It is posted as a Senior Associate - Clinical Safety & Pharmacovigilance role in the Clinical Safety & Pharmacovigilance department at soterius.
Which team or department does the Senior Associate - Clinical Safety & Pharmacovigilance at soterius belong to?
This Senior Associate - Clinical Safety & Pharmacovigilance position is part of the Clinical Safety & Pharmacovigilance department at soterius. See the full job description for more information about the team structure and responsibilities.
How do I apply for the Senior Associate - Clinical Safety & Pharmacovigilance position at soterius?
Click the "Apply Now" button on this page. You will be redirected to soterius's official application portal hosted on keka where you can submit your application directly.
When was the Senior Associate - Clinical Safety & Pharmacovigilance job at soterius posted?
This Senior Associate - Clinical Safety & Pharmacovigilance position at soterius was posted on Jul 31, 2026. Apply as soon as possible — early applications are often reviewed first.
Senior Associate - Clinical Safety & Pharmacovigilance
soterius
You'll be redirected to soterius's official application page on keka.