Senior Drug Safety Specialist
Company: OrciMed Life Sciences Private Limited
- Location: Manila, Philippines
- Work mode: Remote
- Seniority: Senior
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
About the Role
We are looking for a Senior Drug Safety Specialist with strong expertise in ICSR (Individual Case Safety Report) Submissions to support global pharmacovigilance operations. The role is primarily focused on the preparation, review, tracking, and submission of safety reports to regulatory authorities, ethics committees, investigators, and sponsors while ensuring compliance with global regulatory requirements and reporting timelines.
Key Responsibilities
- Prepare, review, and submit ICSRs and expedited safety reports to regulatory authorities, ethics committees, investigators, and sponsors.
- Ensure timely and accurate submission of serious adverse events (SAEs), SUSARs, and other reportable safety cases in accordance with global regulations and client requirements.
- Review safety reports and source documentation for completeness, accuracy, and regulatory compliance prior to submission.
- Track and maintain submission records to ensure compliance with reporting timelines.
- Monitor submission mailboxes and manage safety report distribution activities.
- Coordinate with internal teams, sponsors, CRO partners, and study stakeholders regarding submission-related activities.
- Support the reconciliation, tracking, and documentation of safety reporting activities.
- Identify and escalate reporting issues, delays, or compliance risks.
- Maintain inspection-ready documentation and support audit activities.
- Contribute to process improvements and reporting compliance initiatives.
Qualifications
- Bachelor's degree in Pharmacy, Nursing, Life Sciences, or a related field.
- Minimum 3 years of experience in Pharmacovigilance or Drug Safety.
- Strong experience in ICSR Submissions, Safety Reporting, and Regulatory Reporting.
- Solid understanding of global pharmacovigilance regulations and reporting requirements.
- Experience handling SAE, SUSAR, and adverse event reporting activities.
- Familiarity with submission tracking, compliance monitoring, and health authority reporting processes.
- Excellent attention to detail and ability to meet strict regulatory timelines.
- Strong communication and stakeholder management skills.
Preferred Systems Experience
- Argus Safety
- ARISg
- PV Edge
- Veeva Vault Safety
- Electronic Data Capture (EDC) Systems
Why Join Us?
✅ 100% Work From Home Setup
✅ Company-Provided Equipment
✅ Global Pharmacovigilance Exposure
✅ Night Shift
