Sr. Pharmacovigilance

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.


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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 accommodationrequest@advancedgroup.com.