Sr. Pharmacovigilance

Advanced Clinical; South San Francisco (CA); On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Health coverage

Life insurance

Disability insurance

401k benefits

Job summary

Advanced Group is seeking a Senior PV Clinical Scientist to drive pharmacovigilance operations, including AE case management, clinical review and compliance monitoring. The role will serve as an expert for ICSRs, ensuring accurate safety data processing and reporting while supporting quality initiatives.

The position requires 5–7 years PV experience, strong knowledge of regulatory requirements, and demonstrated skills in writing, analytics, and project leadership.

Qualifications

• Healthcare professional degree required (Nursing/Pharmacy/Medicine or related clinical discipline).
• 5–7 years of pharmacovigilance experience in pharma/biotech/healthcare or related field.
• Strong knowledge of ICSR processing, PV operations, and clinical safety review.
• Thorough understanding of FDA/EMA/ICH/GVP/global PV requirements.
• Experience with vendor oversight, compliance activities, and process improvements.
• Strong technical writing, analytical, and project management skills.
• Proficiency with safety databases and MS Office apps.
• Excellent communication and organizational skills.

Responsibilities

• Perform clinical review and quality oversight of ICSRs.
• Assess adverse event information for completeness, seriousness, causality, and labeling impact.
• Monitor case quality, compliance metrics, vendor performance, and safety trends.
• Ensure compliance with global pharmacovigilance regulations and reporting requirements.
• Support investigations, audits, inspections, and process improvements.
• Author and maintain SOPs, training materials, and compliance documentation.
• Develop quality metrics, trend analyses, reports, and leadership presentations.
• Serve as SME for safety systems, case processing and PV operations.
• Collaborate with internal teams and external partners on safety activities and data exchange.
• Provide training and guidance to staff and vendors.

Skills

Adverse event processing

ICSR management

Clinical review

Technical writing

Project management

Safety databases

Microsoft Office

Communication

Organizational skills

Education

Nursing/Pharmacy/Medicine degree

Tools

Safety databases

Microsoft Office

Job description

We are seeking a Senior PV Clinical Scientist to support pharmacovigilance operations, including adverse event case management, clinical review, compliance monitoring, and vendor oversight. This role serves as a subject matter expert for Individual Case Safety Reports (ICSRs), ensuring the accurate processing, evaluation, and reporting of safety data while supporting quality and process improvement initiatives.

Position Overview

We are seeking a Senior PV Clinical Scientist to support pharmacovigilance operations, including adverse event case management, clinical review, compliance monitoring, and vendor oversight. This role serves as a subject matter expert for Individual Case Safety Reports (ICSRs), ensuring the accurate processing, evaluation, and reporting of safety data while supporting quality and process improvement initiatives.

Key Responsibilities

• Perform clinical review and quality oversight of Individual Case Safety Reports (ICSRs).
• Assess adverse event information for completeness, validity, seriousness, causality, and labeling impact.
• Monitor case quality, compliance metrics, vendor performance, and safety trends; identify risks and support corrective actions.
• Ensure compliance with global pharmacovigilance regulations and reporting requirements.
• Support investigations, reconciliations, audits, inspections, and process improvement initiatives.
• Author and maintain SOPs, training materials, operational procedures, and compliance documentation.
• Develop quality metrics, trend analyses, reports, and presentations for leadership and stakeholders.
• Serve as a subject matter expert for safety systems, case processing, and pharmacovigilance operations.
• Collaborate with internal teams and external partners to support safety-related activities and data exchange.
• Provide training and guidance to internal staff and vendor teams.

Required Qualifications

• Healthcare professional degree such as Nursing, Pharmacy, Medicine, or a related clinical discipline.
• 5-7 years of pharmacovigilance experience within the pharmaceutical, biotechnology, healthcare, or related industry; equivalent clinical safety experience may be considered.
• Strong knowledge of adverse event case processing, ICSR management, and pharmacovigilance operations.
• Thorough understanding of FDA, EMA, ICH, GVP, and global pharmacovigilance requirements.
• Experience performing clinical review and medical assessment of safety cases.
• Experience supporting vendor oversight, compliance activities, and process improvements.
• Strong technical writing, analytical, and project management skills.
• Proficiency with safety databases and Microsoft Office applications.
• Excellent communication and organizational skills.

Preferred Qualifications

• Experience supporting regulatory submissions, inspections, or health authority interactions.
• Experience with quality trend analysis, compliance monitoring, and vendor management.
• Experience with safety data reconciliation and case transmission processes.
• Prior leadership, mentoring, or subject matter expert experience within pharmacovigilance.
• Experience working in a global pharmacovigilance environment.

Benefits

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

Diversity & Inclusion

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 [e-mail].