Drug Safety Specialist
Job Summary The Clinical Medical Services Specialist III provides medical and pharmacovigilance support focused on the intake, assessment, and processing of adverse event information. This role oversees external vendors to ensure compliance with global regulatory requirements, supports case quality initiatives, and collaborates with cross-functional teams to maintain high standards of patient safety, quality, and regulatory compliance.
Key Responsibilities
- Oversee external vendors to ensure timely 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 quality, compliance, productivity, and adherence to established standards.
- Support case quality initiatives, processing metrics, and continuous 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 Quality Assurance and Customer Service teams regarding product quality issues involving adverse events.
- Provide medical information support utilizing approved product labeling and standard communication resources.
- Support special projects and additional responsibilities based on business needs.
Required Qualifications
- Bachelor’s degree in Life Sciences or a related healthcare discipline.
- Registered Nurse, 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 related healthcare 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 Healthcare products Regulatory Agency guidelines.
- Understanding of adverse event reporting, case management, causality assessment, and safety surveillance processes.
- Ability to lead projects and manage multiple priorities in a fast-paced environment.
- Strong communication, collaboration, and problem-solving skills.
Preferred Qualifications
- Pharmacovigilance experience within the pharmaceutical, biotechnology, or healthcare 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 within a clinical or safety environment.
Benefits
The Company offers the following benefits for this position, subject to applicable eligibility requirements medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable. Pay Range $30/hr to $38/hr Apply To this Job