Position Overview
We are seeking a Pharmacovigilance Specialist to support global drug safety activities, including adverse event management, safety reporting, regulatory compliance, and pharmacovigilance operations.
Key Responsibilities
- Process and follow up on adverse event reports and safety cases.
- Support safety reporting, signal detection, and literature review activities.
- Maintain safety databases and pharmacovigilance documentation.
- Support audits, inspections, CAPA activities, and compliance initiatives.
- Assist with SOP updates, training, and process improvements.
- Collaborate with internal and external stakeholders on pharmacovigilance activities.
Required Qualifications
- Experience in Pharmacovigilance, Drug Safety, Clinical Safety, or a related field.
- Experience with adverse event case processing and safety reporting.
- Knowledge of pharmacovigilance regulations and compliance requirements.
- Experience with safety databases and safety documentation.
- Strong analytical, organizational, and communication skills.
Preferred Qualifications
- Experience with signal detection, periodic safety reporting, or risk management.
- Experience supporting audits, inspections, or CAPA activities.
- Experience developing SOPs or pharmacovigilance procedures.
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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].