Sr. Pharmacovigilance Clinical Scientist

Dawar Consulting, Inc.; South San Francisco (CA); Hybrid; USD 82.656 - 103.320; Vollzeit

Benefits dieser Stelle

Medical

Dental

Vision

Paid Sick leave

401K

Zusammenfassung

JobRx, Inc. in South San Francisco, CA, seeks a Sr. Pharmacovigilance Clinical Scientist for a long-term contract in a hybrid role.

You will provide expert clinical review of AE/ICSR cases, ensure regulatory compliance, and lead safety process improvements with internal teams and vendors. The role requires 5–7+ years in pharmacovigilance, strong ICSR experience, and solid writing and project-management skills.

Qualifikationen

• Healthcare professional degree such as RN/BSN/MSN, PharmD, RPh/BPharm, NP, MD.
• 5-7+ years of pharmacovigilance experience in a biopharmaceutical environment.
• Strong experience with ICSR case processing and clinical review.
• Knowledge of FDA, ICH, EMA, GVP, and global pharmacovigilance regulations.
• Experience with medical/scientific writing, data entry, and project management.
• Strong analytical, communication, organizational, and problem-solving skills.
• Ability to work independently, manage complex issues, and collaborate effectively with internal teams and external vendors.

Aufgaben

• Conduct clinical review and quality assessment of AE/ICSR cases processed internally or by vendors.
• Evaluate case validity, seriousness, causality, labeling, and follow-up requirements.
• Ensure accurate and timely case processing in the global safety database.
• Monitor case quality, error trends, vendor performance, and potential compliance risks.
• Support PV compliance with FDA, ICH, EMA, GVP, and applicable global regulations.
• Lead process improvements, SOP updates, training initiatives, and quality trend reporting.
• Support vendor oversight, audits, inspections, reconciliations, and case transmission verification.
• Oversee follow-up activities, correspondence, and data corrections.
• Support technical and medical product complaint reporting and escalation.
• Collaborate with cross-functional teams and serve as a subject matter expert for safety-related activities.
• Prepare presentations, executive summaries, and scientific/medical documentation.

Kenntnisse

Pharmacovigilance

ICSR processing

Clinical review

Regulatory knowledge

Medical writing

Project management

Analytical skills

Ausbildung

Healthcare professional degree (RN/BSN/MSN, PharmD, RPh/BPharm, NP, MD)

Jobbeschreibung

Job Description

Our client, a world leader in biotechnology and gene therapy, is looking for an "Sr. Pharmacovigilance Clinical Scientist" based in South San Francisco, CA (Hybrid).

Job Duration: Long Term Contract (Possibility Of Extension)

Pay Rate : $65/hr on W2

Company Benefits:

• Medical
• Dental
• Vision
• Paid Sick leave
• 401K

The Sr. PV Clinical Scientist supports US Patient Safety by providing expert clinical review, evaluation, and quality oversight of Individual Case Safety Reports (ICSRs) and adverse event (AE) information. This role ensures case processing, follow-up, labeling assessments, and Health Authority submissions comply with company SOPs, PV regulations, and applicable global requirements.

The position works autonomously as a subject matter expert, supports vendor oversight, drives quality and process improvements, and may lead projects and train internal and external teams.

Key Responsibilities

• Conductclinical review and quality assessment of AE/ICSR cases processedinternally or by vendors.
• Evaluatecase validity, seriousness, causality, labeling, and follow-uprequirements.
• Ensureaccurate and timely case processing in the global safety database.
• Monitorcase quality, error trends, vendor performance, and potential compliancerisks.
• SupportPV compliance with FDA, ICH, EMA, GVP, and applicable global regulations.
• Leadprocess improvements, SOP updates, training initiatives, and quality trendreporting.
• Supportvendor oversight, audits, inspections, reconciliations, and casetransmission verification.
• Overseefollow-up activities, correspondence, and data corrections.
• Supporttechnical and medical product complaint reporting and escalation.
• Collaboratewith cross-functional teams and serve as a subject matter expert forsafety-related activities.
• Preparepresentations, executive summaries, and scientific/medical documentation.

Required Qualifications

• Healthcareprofessional degree such as RN/BSN/MSN, PharmD, RPh/BPharm, NP, MD,or related qualification.
• 5-7+years of pharmacovigilance experience in a biopharmaceutical environment or equivalentclinical experience with strong knowledge of safety regulations.
• Strongexperience with ICSR case processing and clinical review.
• Knowledgeof FDA, ICH, EMA, GVP, and global pharmacovigilance regulations.
• Experiencewith medical/scientific writing, data entry, and project management.
• Stronganalytical, communication, organizational, and problem-solving skills.
• Abilityto work independently, manage complex issues, and collaborate effectivelywith internal teams and external vendors.