Sr. Pharmacovigilance
Company: Advanced Clinical
- Location: South San Francisco, United States
- Seniority: Senior
- Employment type: Contract
- Posted: 12 days ago
- Offer language: English
Job description
Position Overview
We are seeking a Senior PV Clinical Scientist to support pharmacovigilance operations through safety case review, compliance oversight, quality management, and regulatory reporting activities. This role will help ensure the quality, accuracy, and compliance of safety data and reporting processes.
Key Responsibilities
- Review and evaluate adverse event reports and Individual Case Safety Reports (ICSRs).
- Support case processing, medical review, follow-up activities, and safety data quality.
- Monitor compliance trends, quality metrics, and vendor performance.
- Contribute to regulatory reporting, safety documentation, and compliance activities.
- Support SOP development, training, audits, inspections, and process improvement initiatives.
- Collaborate with internal teams and external partners on safety and compliance activities.
Required Qualifications
- Healthcare professional degree (e.g., RN, NP, Pharmacist, PharmD, or MD).
- 5-7+ years of experience in pharmacovigilance, drug safety, or related clinical functions.
- Experience with ICSR processing, adverse event reporting, and safety data review.
- Knowledge of FDA, EMA, ICH, and global pharmacovigilance requirements.
- Experience supporting compliance, vendor oversight, and regulatory activities.
- Strong analytical, scientific writing, project management, and communication skills.
Preferred Qualifications
- Experience supporting pharmacovigilance compliance or safety quality programs.
- Experience with safety databases, audits, inspections, or reconciliation activities.
- Experience developing SOPs, training materials, or quality improvement initiatives.
#MSPTalent
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 accommodationrequest@advancedgroup.com.
