Senior PV Clinical Scientist

Senior PV Clinical Scientist ROCGJP00043845

• Hourly pay: $55-$65/hr
• Worksite: Leading biotechnology company (South San Francisco, CA 94080 - Hybrid)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 7 Month Assignment

A leading biotechnology company is seeking a Senior PV Clinical Scientist to lead clinical review and processing of adverse event information and support pharmacovigilance compliance.

Sr. PV Clinical Scientist Responsibilities:

• Complete drug safety monitoring and tracking according to pharmacovigilance (PV) standards, regulations, and SOPs. Triage, evaluate, and verify potential adverse event (AE) information, enter cases into the global safety database, and perform seriousness, validity, causality, and labeling assessments, quality reviews, and follow-up, including due diligence to obtain missing information and leading clinical review of cases processed in-house and by vendors.
• Lead efforts to keep Individual Case Safety Reports (ICSRs) and Health Authority submissions at company and local regulatory standards, maintaining in-depth knowledge of ICSR requirements for assigned therapeutic areas, evaluating error rates and compliance impact, analyzing vendor case processing trends and escalating issues, ensuring data corrections in the safety database, and developing quarterly executive summaries on quality trends.
• Help management oversee GVP vendors by identifying case processing risks and gaps and monitoring feedback. Maintain follow-up templates and ensure follow-up attempts are transmitted through the correspondence module, reconcile outgoing communications, support AE reconciliation and Case Transmission Verification (CTV), and ensure technical and medical product complaints, including those for combination products, reach the right stakeholders on time.
• Create and update SOPs and training documents, perform impact assessments for new or updated SOPs and Health Authority requirements and implement resulting process changes, lead process improvement initiatives, train internal staff and vendors to ensure PV compliance, and prepare and deliver patient safety presentations.
• Serve as the single point of contact and subject matter expert for safety-related activities in the global safety database, collaborating with departments, partners, and other patient safety teams on drug safety data exchange, identifying business gaps, leading assigned projects, coaching less experienced colleagues, and supporting audits and inspections.

Sr. PV Clinical Scientist Qualifications:

• 5-7 years of pharmacovigilance experience in a biopharma company is preferred, OR
• Equivalent clinical experience with a thorough understanding of FDA safety regulations and submissions, ICH guidelines, EMA regulations, and the global PV regulatory environment.
• Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/BPharm/PharmD, or MD).
• Science/medical writing experience.
• Computer proficiency and data entry experience.
• Project management experience.
• Ability to travel domestically and internationally as business needs require.

Shift:

• Hybrid: Monday to Friday, 8:00 AM to 4:30 PM PT.

(H)

Science | Hybrid in South San Francisco, CA | Full Time, Contract, and Temporary | From $55.00 to $65.00 per hour