Sr. Pharmacovigilance (PV) Clinical Scientist

Key Accountabilities

• Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Roche Standard Operating Procedures (SOPs)
• Reviews, evaluates, and verifies potential AE information during triage to determine required action per internal policies and procedures and perform data entry of adverse events by timely completion of the case via Roche global safety database.
• Performs seriousness / validity/causality and conducts quality review of all cases (as applicable) based on their medical assessment
• Performs labeling assessment for AE(s) received using clinical knowledge and conducted follow up for all reported cases (as applicable)
• Responsible for leading efforts to ensure quality of Individual Case Safety Reports (ICSRs) is at par with company standards
• Responsible for maintaining thorough knowledge of ICSR requirements for assigned Therapeutic Areas (TA)
• Performs trend analysis of vendor case processing issues for assigned TA and escalates to vendor, TA Leads and US Government Client management as applicable
• Updates and create SOPs; lead process improvement initiatives
• Responsible for developing executive summary on the quality trends observed on a quarterly basis
• Ensures quality of Health Authority (HA) submissions is at par with local regulations
• Responsible for Clinical Review of cases processed in-house and by vendors
• Understands case processing data to evaluate error rates and potential compliance impact
• Responsible for training internal US Government Client and/or vendors staff or team and ensure PV compliance
• Collaborate with departments and partners on drug safety data exchange
• Responsible for ensuring appropriate data correction in the safety database for identified issues or errors
• Maintains robust knowledge of Technical Product Complaints (TPC) & Medical Product Complaint (MPC) for all company products including combination products
• Responsible for ensuring all product complaints are reported to the appropriate stakeholders within defined timelines
• Ensures appropriate due diligence to obtain missing and/or additional information for Adverse Events (AEs) is performed in accordance with company SOPs / local and global regulations
• Escalates any issues pertaining to follow up activities and provide strategic resolution to US Government Client management
• Affords oversight for GVP vendors
• Identifies the risks and gaps pertaining to case processing for GVP Vendors
• Continuously monitors feedback to inform quality improvements and updates
• Responsible for performing impact assessment for any new / updated company SOPs or Health Authority requirements pertaining to ICSR processing and implements any process changes required based on the identified impact
• Responsible for identifying and developing training documents (i.e., SOPs) for the targeted audience (as needed)
• Assists in AE reconciliation activities and/or Case Transmission Verification (CTV) (as applicable)
• Acts as single point of contact with key stakeholders for safety-related activities, identifies potential business gaps, and assists in the development and implementation of process solutions, and leads projects as assigned and under the direction of the US Patient Safety PV Clinical management
• Responsible for the preparation and development of Patient Safety presentations and participates in the education offer internal /external stakeholders/vendors as applicable
• Provides support during audits and inspections
• Collaborates with other patient safety teams as needed

Competencies Identified for Success

• Demonstrates capability to comprehend medical information
• Demonstrates ownership, initiative and accountability
• Sounds decision-making abilities as demonstrated by systematic gathering of information, appropriately assessing the complexity of issues, and prioritization of tasks in a timely manner within the scope of responsibility
• Demonstrates strong, dynamic leadership skills
• Works well independent or within teams and is effective in collaborating with others internally and externally
• Ability to exercise independent judgment and discretion in matters of significance
• Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
• Communication and presentation skills; highly effective at summarizing and presenting key considerations and decision-points
• Ability to flex and thrive in an agile and fast-changing environment
• Strong attention-to-detail
• Strong attention-to-detail in establishing priorities and meeting deadlines
• Strong project management skills

Education, Experience, and Other Requirements

• Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD) (Required)
• Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance responsibilities (Preferred); OR equivalent clinical experience with thorough understanding of FDA safety regulations, ICH guidelines, and other applicable regulatory guidance documents, global PV regulatory environment, EMA regulations (Required)
• Writing experience; science/medical writing (Required)
• Computer proficiency and Data entry experience (Required)
• Project Management (Required)