Sr. Pharmacovigilance (PV) Clinical Scientist

• Conducts drug safety monitoring and adverse event (AE) case processing, including triage, data entry, assessments, labeling review, follow-up, and quality review in compliance with PV regulations and Genentech/Roche SOPs.
• Ensures quality and regulatory compliance of ICSRs, Health Authority submissions, and safety database data.
• Performs clinical review of cases, trend analysis, error assessment, vendor oversight, and implements corrective actions and process improvements.
• Develops, updates, and assesses SOPs, training materials, and process changes related to safety reporting requirements.
• Trains internal and vendor staff, maintains correspondence processes, and monitors PV compliance.
• Oversees product complaint reporting (TPC/MPC), AE follow-up activities, reconciliation, and Case Transmission Verification (CTV) as applicable.
• Serves as SME and primary contact for safety-related activities, supports audits and inspections, prepares presentations, leads projects, and collaborates with stakeholders and patient safety teams.

• Health Care Background (RN/BSN/MSN, NP, RPh/B, Pharm/PharmD
• Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance responsibilities (Preferred)
• Thorough understanding of FDA safety regulations, ICH guidelines, and other applicable regulatory guidance documents, global PV regulatory environment, EMA regulations 
• Writing experience; science/medical writing (Required)
• Computer proficiency and Data entry experience (Required)
• Project Management (Required)

Only applicable for Kentucky positions: For this type of employment, state law requires a criminal record check as a condition of employment. This applies to direct care staff (Examples: RN, LPN, Nurse Aides, Therapists) referred to Kentucky nursing facilities, assisted living communities, or long-term care facilities, in accordance with KRS 216.793.



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