Sr. Pharmacovigilance (PV) Clinical Scientist

Sr. Pharmacovigilance (PV) Clinical Scientist

Hybrid, South San Francisco, CA

Pay Rate: Up to $60-65/hr. W2

Duration: 7+ months, long term project, with annual extensions

Working Hours: 8:00 AM to 4:30 PM PT

Working Days: Monday through Friday

Interview Format:

• Round 1: Hiring Manager (30 minutes)
• Round 2: Upper Management (30 minutes)

Summary of Position

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 skills to projects.
• May act as coach for colleagues with less experience and provide guidance.

Key Accountabilities

Drug Safety Monitoring & Case Processing

• 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 performs data entry of adverse events by timely completion of the case via the Roche global safety database.
• Performs seriousness, validity, and causality assessments and conducts quality review of all cases (as applicable) based on medical assessment.
• Performs labeling assessment for AE(s) received using clinical knowledge and conducts follow-up for all reported cases (as applicable).

Quality & Compliance

• 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 vendors, TA Leads, and USPS management as applicable.
• Updates and creates SOPs; leads process improvement initiatives.
• Responsible for developing executive summaries on 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 vendor staff and ensuring PV compliance.

Safety Data Management

• Collaborates 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 and ensuring successful transmission of all follow-up attempts performed by PV Compliance Team Scientists/Vendor staff via the correspondence module.
• Accountable for training internal and external staff members on using the correspondence module.
• Performs reconciliation of outgoing communications.

Product Complaints

• Maintains robust knowledge of Technical Product Complaints (TPC) and Medical Product Complaints (MPC) for all company products, including combination products.
• Responsible for ensuring all product complaints are reported to the appropriate stakeholders within defined timelines.

Follow-Up & Due Diligence

• Ensures appropriate due diligence to obtain missing and/or additional information for Adverse Events (AEs) is performed in accordance with company SOPs and local/global regulations.
• Escalates any issues pertaining to follow-up activities and provides strategic resolution to USPS management.

Vendor Oversight

• Assists USPS management in maintaining oversight for GVP vendors.
• Identifies risks and gaps pertaining to case processing for GVP vendors.
• Continuously monitors feedback to inform quality improvements and updates.

Regulatory & Process Management

• Responsible for performing impact assessments for any new/updated company SOPs or Health Authority requirements pertaining to ICSR processing and implements any required process changes.
• Responsible for identifying and developing training documents (e.g., SOPs) for the targeted audience as needed.
• Assists in AE reconciliation activities and/or Case Transmission Verification (CTV), as applicable.

Stakeholder Management & Leadership

• Acts as a 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.
• Leads projects as assigned and under the direction of the US Patient Safety PV Clinical Management.

Training, Presentations & Audits

• Responsible for preparation and development of Patient Safety presentations.
• Participates in education of internal/external stakeholders and vendors, as applicable.
• Acts as Subject Matter Expert (SME) for safety-related activities within the Global Safety Database per Genentech/Roche SOPs.
• 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.
• Sound decision-making abilities as demonstrated by:
• Systematic gathering of information.
• Appropriate assessment of issue complexity.
• Timely prioritization of tasks within scope of responsibility.
• Demonstrates strong, dynamic leadership skills.
• Works well independently and within teams.
• 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.
• Strong 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 business needs require.

Education, Experience, and Other Requirements

Education:

Health Care Professional degree (Required), such as: RN, BSN, MSN, NP, RPh, B Pharm, Pharm D, MD

Experience 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 and submissions
• ICH guidelines
• Other applicable regulatory guidance documents
• Global PV regulatory environment
• EMA regulations