Sr. Pharmacovigilance (PV) Clinical Scientist

Software Guidance & Assistance, Inc., (SGA), is searching for a Sr. Pharmacovigilance (PV) Clinical Scientist for a contract assignment with one of our premier Pharmaceutical clients in San Francisco, CA .

The US Patient Safety Sr. PV Clinical Scientist - Pharmacovigilance (PV) Compliance Team performs the tactical and operational job responsibilities, including but not limited to the collection, clinical review, evaluation, and processing of adverse event (AE) information received by US Patient Safety. The Sr. PV Clinical Scientist leads clinical review of USPS cases (processed in-house or externally by the vendor) and supports the US Patient Safety PV Clinical Associate Group Director and PV Clinical Group Director-PV Compliance Team in all activities. All responsibilities are performed under the direction of the US Patient Safety PV Clinical Management. Contributes in depth knowledge of Individual Case Safety Reports (ICSRs) case processing. Has developed a variety of skills typically gained through years of professional experience. Works autonomously with minimal supervision. May lead or contribute with skills to projects. May act as coach for colleagues with less experience and provide guidance.

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

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SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .

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