Sr. Pharmacovigilance (PV) Clinical Scientist

1. Hiring Manager – 30 minutes
2. Upper Management – 30 minutes

• Perform timely, accurate, and thorough drug safety monitoring and tracking in accordance with pharmacovigilance standards, applicable regulations, and Genentech/Roche SOPs.
• Review, evaluate, and verify potential adverse event information during case triage and determine appropriate actions based on internal procedures.
• Perform data entry and complete adverse event cases in the Roche Global Safety Database within required timelines.
• Conduct clinical assessments, includingseriousness, validity, causality, and quality review of cases, as applicable.
• Perform labeling assessments for reported adverse events and coordinate appropriate follow-up activities.
• Lead efforts to ensure the quality and completeness ofIndividual Case Safety Reports (ICSRs) meet company standards.
• Maintain strong knowledge of ICSR processing requirements for assigned therapeutic areas.
• Conduct trend analysis of vendor case-processing issues and escalate identified concerns to vendors, Therapeutic Area Leads, and US Patient Safety management.
• Create and update SOPs and lead process improvement initiatives.
• Develop quarterly executive summaries highlighting observed quality trends and key findings.
• Ensure the quality and compliance of Health Authority submissions in accordance with applicable local regulations.
• Perform clinical review of cases processed both internally and by external vendors.
• Analyze case-processing data to evaluate error rates, identify trends, and assess potential compliance impact.
• Develop and deliver PV training for internal US Patient Safety personnel and/or vendor teams.
• Collaborate with internal departments and external partners on drug safety data exchange activities.
• Ensure appropriate corrections are made in the safety database for identified errors or data issues.
• Maintain follow-up templates and ensure successful transmission of follow-up communications through the correspondence module.
• Train internal and external personnel on the use of the correspondence module and perform reconciliation of outgoing communications.
• Maintain knowledge ofTechnical Product Complaints (TPC) andMedical Product Complaints (MPC) across company products, including combination products.
• Ensure product complaints are appropriately reported to relevant stakeholders within established timelines.
• Conduct appropriate due diligence to obtain missing or additional information related to adverse events in accordance with company SOPs and applicable regulations.
• Escalate follow-up issues to US Patient Safety management and assist in developing appropriate resolutions.
• Support US Patient Safety management in overseeingGood Pharmacovigilance Practice (GVP) vendors.
• Identify risks and gaps in vendor case processing and monitor feedback to drive continuous quality improvements.
• Perform impact assessments for new or updated company SOPs and Health Authority requirements related to ICSR processing.
• Implement necessary process changes based on identified impacts and requirements.
• Identify and develop training materials, SOPs, and other documentation for targeted audiences as needed.
• Support AE reconciliation activities and/or Case Transmission Verification (CTV), as applicable.
• Serve as a key point of contact for safety-related activities and collaborate with stakeholders to identify business gaps and develop process solutions.
• Lead projects and process initiatives as assigned by US Patient Safety PV Clinical Management.
• Prepare Patient Safety presentations and support educational activities for internal and external stakeholders and vendors.
• Serve as aSubject Matter Expert (SME) for safety-related activities within the Global Safety Database and ensure alignment with Genentech/Roche SOPs.
• Provide support during audits, inspections, and regulatory activities.
• Collaborate with other Patient Safety teams as required.

• Strong ability to understand, interpret, and assess complex medical information.
• Demonstrated ownership, initiative, accountability, and attention to detail.
• Strong decision-making skills with the ability to gather information, assess complex issues, and prioritize tasks effectively.
• Strong leadership and collaboration skills.
• Ability to work independently and effectively within cross-functional teams.
• Ability to exercise sound independent judgment and discretion.
• Experience working with complex issues requiring in-depth analysis and evaluation of multiple factors.
• Excellent written, verbal, communication, and presentation skills.
• Ability to summarize complex information and clearly communicate key considerations and decisions.
• Adaptability and ability to thrive in an agile, fast-changing environment.
• Strong organizational skills with the ability to establish priorities and consistently meet deadlines.
• Strong project management capabilities.
• Willingness and ability to travel domestically and internationally based on business needs.

• Required: Healthcare Professional degree, such as:
  • RN / BSN / MSN
  • Nurse Practitioner (NP)
  • RPh / B.Pharm / Pharm.D.
  • MD
• Required: Minimum5–7 years of experience in a biopharmaceutical company with Pharmacovigilance responsibilities, or equivalent clinical experience.
• Strong understanding of:
  • FDA safety regulations and submission requirements
  • ICH guidelines
  • Global pharmacovigilance regulations and requirements
  • EMA regulations
  • Applicable regulatory guidance and standards
• Required: Experience with scientific and/or medical writing.
• Required: Strong computer proficiency and data-entry experience.
• Required: Project management experience.
• Strong knowledge ofICSR case processing and clinical safety assessment preferred.
• Experience working with global safety databases and PV vendors is highly preferred

At Tailored Management, we help people get jobs and take pride in their work, so we better take pride in ours too. Not every company has the opportunity to meaningfully and directly impact individuals in a way that makes their lives tangibly better. To better support our employees, we offer a wide variety of benefit options to support you. We offer:

• Medical Coverage– HDHP, PPO, and Surest plan options
• Minimum Essential Coverage (MEC)
• Dental Insurance
• Vision Insurance
• Short-Term Disability (STD)
• Long-Term Disability (LTD)
• Life & AD&D Insurance
• Critical Illness Insurance
• Accident Insurance
• Employee Assistance Program (EAP)