Senior Drug Safety Specialist - Submission

Senior Pharmacovigilance Specialist – Submission

📍 100% Work From Home | 💻 Company-Provided Laptop | 🌙 Night Shift

About the Role
We are seeking a Senior Pharmacovigilance Specialist – Submission to join our Pharmacovigilance team. This position is responsible for the preparation, review, tracking, and submission of safety reports to Regulatory Authorities, Ethics Committees, Institutional Review Boards (IRBs), and Investigators in compliance with global pharmacovigilance regulations and reporting timelines.

The ideal candidate will have strong experience in expedited reporting, regulatory submissions, safety reporting compliance, and clinical trial pharmacovigilance.

Key Responsibilities

• Prepare, review, and submit expedited safety reports, including SAEs, SUSARs, ICSRs, and aggregate safety reports, within required regulatory timelines.
• Ensure timely submission of safety reports to Regulatory Authorities, Ethics Committees, IRBs, Investigators, and Sponsors.
• Monitor safety reporting inboxes and manage submission workflows to ensure compliance with global and local reporting requirements.
• Review safety cases and supporting documentation to ensure accuracy, completeness, and compliance before submission.
• Track submission timelines and maintain accurate submission records and documentation.
• Manage regulatory reporting logs, submission trackers, and reporting metrics.
• Collaborate with Case Processing teams to ensure reportable cases are identified and submitted on time.
• Support reconciliation activities and respond to submission-related queries and audit requests.
• Participate in quality reviews and compliance checks to ensure adherence to SOPs, client requirements, and applicable regulations.
• Support inspections, audits, and regulatory assessments by maintaining complete and submission-ready records.
• Contribute to process improvements and reporting efficiency initiatives.

QualificationsRequired

• Bachelor’s Degree in Pharmacy, Nursing, Life Sciences, Medical Technology, Biology, or a related healthcare field.
• Minimum of 3 years of Pharmacovigilance or Drug Safety experience.
• Experience in safety reporting and submission activities within Clinical Trials or Post-Marketing Pharmacovigilance.
• Strong understanding of:
• SAE Reporting
• SUSAR Reporting
• ICSR Reporting
• Expedited Reporting Requirements
• Global Pharmacovigilance Regulations
• Clinical Trial Safety Reporting Processes
• Experience working within strict regulatory timelines.
• Strong attention to detail and documentation skills.

Preferred

• Experience with:
• Argus Safety
• ARISg
• PV Edge
• Veeva Vault Safety
• LifeSphere Safety
• Experience supporting submissions to Regulatory Authorities, Ethics Committees, and Investigators.
• Exposure to audit and inspection readiness activities.
• Previous experience in a CRO, pharmaceutical, or biotechnology environment.

Preferred Candidate Profile
We are particularly interested in candidates with experience in:

✅ Safety Reporting Coordination

✅ Expedited Reporting

✅ Regulatory Submission Management

✅ Submission Compliance Monitoring

✅ Safety Report Distribution

✅ Timeline Tracking and Reconciliation

✅ Regulatory Documentation Management

✅ Clinical Trial Safety Operations
What We Offer
✅ 100% Work From Home Setup

✅ Company-Issued Laptop

✅ Competitive Compensation Package

✅ Exposure to Global Clinical Trials and Pharmacovigilance Programs

✅ Collaborative and Supportive Team Environment

📍 Only candidates residing in Metro Manila and neighboring cities/provinces will be considered.

📍 Applicants must currently be based in the Philippines and legally authorized to work in the Philippines.

❌ Applications from candidates outside the Philippines will not be acknowledged or considered.

Interested?

Apply now or send your CV to aeiris.alcantara@orcimedlifesciences.com