Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD)
5-7 years of experience in a biopharma company with Pharmacovigilance responsibilities or equivalent clinical experience
Strong project management skills
Demonstrates strong leadership and communication skills
Ability to analyze complex issues and prioritize tasks effectively
Proficient in data entry and computer skills
Experience in science/medical writing
Responsibilities
Complete drug safety monitoring and tracking in compliance with PV standards and SOPs
Lead efforts to ensure quality of Individual Case Safety Reports (ICSRs)
Perform trend analysis of vendor case processing issues and escalate as needed
Update and create SOPs while leading process improvement initiatives
Develop executive summaries on quality trends quarterly
Train internal and vendor staff on pharmacovigilance compliance
Collaborate with departments on drug safety data exchange
Benefits
Opportunities for professional development and training
Collaborative work environment with cross-departmental engagement
Exposure to global safety database and regulatory compliance
Involvement in process improvement initiatives
Potential for travel to support business needs
Full Job Description
Responsibilities :
Completes drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and Genentech/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 USPS management as applicable
Update 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 USPS 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
Responsible for maintaining follow-up templates, ensuring successful transmission of all follow-up attempts performed by PV Compliance Team Scientist /Vendor staff via the correspondence module
Accountable for training internal and external staff members on using correspondence module
Performs reconciliation of outgoing communications
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 USPS management
Assists USPS management in maintaining 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
Acts as Subject Matter Expert (SME) for safety-related activities within Global Safety Database per Genentech/Roche SOPs
Provide support during audits and inspections
Collaborates with other patient safety teams as needed
Required Skills :
Demonstrates capability to comprehend medical information
Demonstrates ownership, initiative and accountability
Sound 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
Ability to travel domestically and internationally as per business needs
Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD)
Writing experience; science/medical writing
Computer proficiency and Data entry experience
Project Management
Preferred Skills :
Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance responsibilities; OR equivalent clinical experience with thorough understanding of FDA safety regulations and submissions, ICH guidelines, and other applicable regulatory guidance documents, global PV regulatory environment, EMA regulations
