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Senior Safety Specialist
2 months ago
Job Title: Senior Safety Specialist
Job Summary:
We are seeking a highly skilled Senior Safety Specialist to join our Pharmacovigilance Operations team at Gilead Sciences International, Ltd. As a key member of our team, you will be responsible for ensuring compliance with pharmacovigilance activities, including the collection, review, evaluation, processing, and submission of adverse event information.
Key Responsibilities:
- Perform routine and non-routine daily case management activities independently and provide direction as needed to junior staff.
- Lead training and/or on-boarding activities for new team members.
- Lead projects of high complexity and participate in cross-functional projects.
- Develop and/or assist with quality review of data for the applicable functional area.
- Oversee Individual Case Safety Reports (ICSRs) processing performed by vendor(s) and review ICSR compliance.
Requirements:
- Excellent interpersonal and communication skills, both written and oral.
- Excellent computer skills, including Microsoft Office.
- A quality driven individual with strong attention to detail and accuracy.
- Strong organizational skills and ability to adapt to change.
- Safety database and/or data entry experience required.
- Understanding of medical terminology and ability to summarize medical information required.
- Knowledge and experience with safety reporting and regulatory compliance required.
Education & Experience:
Exempt Professional Leveling Guide: 6+ Years with BA/ BS, 4+ Years with MA/ MS
