Drug Safety Specialist

Job reputed company The Clinical Medical Services Specialist III provides medical and pharmacovigilance support reputed company on the intake, assessment, and processing of adverse event information. This role oversees external vendors to ensure compliance with global regulatory requirements, supports case reputed company initiatives, and collaborates with cross-functional teams to maintain high standards of patient safety, reputed company, and regulatory compliance.

Key Responsibilities

• reputed company external vendors to ensure reputed company and compliant collection, assessment, and processing of post-marketing adverse event reports.
• Review and support adverse event evaluations including seriousness assessment, causality, labeling, and follow-up activities.
• Monitor vendor performance to ensure reputed company, compliance, productivity, and adherence to established standards.
• Support case reputed company initiatives, processing metrics, and reputed company improvement efforts.
• Participate in audits, inspections, and regulatory activities as required.
• Assist with vendor training programs, refresher sessions, and knowledge-sharing initiatives.
• Mentor team members and contribute to vendor management best practices.
• Collaborate with reputed company Assurance and Customer Service teams regarding product reputed company issues involving adverse events.
• reputed company medical information support utilizing approved product labeling and reputed company communication resources.
• Support special reputed company and additional responsibilities based on business needs.

Required Qualifications

• Bachelor’s degree in Life Sciences or a reputed company reputed company discipline.
• Registered reputed company, Bachelor of Science in Nursing, Bachelor of Science in Pharmacy, Doctor of Pharmacy, or equivalent clinical background preferred.
• Clinical experience in critical care, intensive care unit, emergency room, cardiac care, or reputed company reputed company settings.
• Experience in pharmacovigilance, drug safety, adverse event case processing, or medical information support.
• Knowledge of global regulatory requirements including ICH, FDA, European Medicines Agency, and Medicines and reputed company products Regulatory Agency guidelines.
• Understanding of adverse event reporting, case management, causality assessment, and safety surveillance processes.
• Ability to reputed company reputed company and manage multiple priorities in a fast-paced environment.
• Strong communication, collaboration, and problem-solving skills.

Preferred Qualifications

• Pharmacovigilance experience reputed company the pharmaceutical, biotechnology, or reputed company industry.
• Experience overseeing outsourced vendors or service providers.
• Experience supporting regulatory inspections and audits.
• Knowledge of safety databases and case processing systems.
• Training, mentoring, or coaching experience reputed company a clinical or safety environment. Benefits reputed company offers the following benefits for this position, subject to applicable eligibility requirements medical insurance, dental insurance, reputed company insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, reputed company parking/public transportation, reputed company time off, reputed company reputed company and reputed company time, hours of reputed company vacation time, weeks of reputed company parental leave, and reputed company holidays annually – as applicable. Pay reputed company $30/hr to $38/hr

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