Sr. Pharmacovigilance (PV) Clinical Scientist

Job Responsibilities:

• Completes drug safety monitoring and tracking in a timely, thorough, and accurate manner in accordance with pharmacovigilance (PV) standards, regulations, and Client’s 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 cases via the Client global safety database.
• Performs seriousness, validity, and causality assessments and conducts quality reviews of all cases, as applicable, based on medical assessment.
• Performs labeling assessments for received AEs using clinical knowledge and conducts follow-up for all reported cases, as applicable.
• Leads efforts to ensure the quality of Individual Case Safety Reports (ICSRs) meets company standards.
• Maintains thorough knowledge of ICSR requirements for assigned Therapeutic Areas (TAs).
• Performs trend analysis of vendor case processing issues for assigned TAs and escalates issues to vendors, TA Leads, and USPS management, as applicable.
• Updates and creates SOPs and leads process improvement initiatives.
• Develops executive summaries on quality trends observed on a quarterly basis.
• Ensures the quality of Health Authority (HA) submissions meets local regulatory requirements.
• Performs clinical reviews of cases processed in-house and by vendors.
• Understands case processing data to evaluate error rates and potential compliance impacts.
• Trains internal USPS and/or vendor staff and ensures PV compliance.
• Collaborates with departments and partners on drug safety data exchange.
• Ensures appropriate data correction in the safety database for identified issues or errors.
• Maintains follow-up templates and ensures successful transmission of all follow-up attempts performed by PV Compliance Team Scientists and vendor staff via the correspondence module.
• Trains internal and external staff members on the use of the correspondence module.
• Performs reconciliation of outgoing communications.
• Maintains robust knowledge of Technical Product Complaints (TPC) and Medical Product Complaints (MPC) for all company products, including combination products.
• Ensures all product complaints are reported to appropriate stakeholders within defined timelines.
• Ensures appropriate due diligence to obtain missing and/or additional AE information in accordance with company SOPs and local and global regulations.
• Escalates issues related to follow-up activities and provides strategic resolutions to USPS management.
• Assists USPS management in maintaining oversight of Good Pharmacovigilance Practices (GVP) vendors.
• Identifies risks and gaps pertaining to vendor case processing and continuously monitors feedback to inform quality improvements and updates.
• Performs impact assessments for new or updated company SOPs and Health Authority requirements pertaining to ICSR processing and implements necessary process changes.
• Identifies and develops training documents, including SOPs, for targeted audiences as needed.
• Assists in AE reconciliation activities and/or Case Transmission Verification (CTV), as applicable.
• Acts as the single point of contact with key stakeholders for safety-related activities, identifies potential business gaps, assists in developing and implementing process solutions, and leads assigned projects under the direction of US Patient Safety PV Clinical Management.
• Prepares and develops Patient Safety presentations and participates in educating internal and external stakeholders and vendors, as applicable.
• Acts as a Subject Matter Expert (SME) for safety-related activities within the Global Safety Database in accordance with Client SOPs.
• Provides support during audits and inspections.
• Collaborates with other patient safety teams as needed.

Skills:

• Demonstrates the ability to comprehend medical information.
• Demonstrates ownership, initiative, and accountability.
• Exercises sound decision-making by systematically gathering information, assessing issue complexity, and prioritizing tasks within the scope of responsibility.
• Demonstrates strong, dynamic leadership skills.
• Works effectively independently and within teams, collaborating with internal and external stakeholders.
• Exercises independent judgment and discretion in matters of significance.
• Handles complex issues requiring in-depth evaluation of variable factors and data.
• Demonstrates strong communication, medical writing, and presentation skills, including summarizing key considerations and decision points.
• Adapts effectively to an agile and fast-changing environment.
• Demonstrates strong attention to detail in case review, documentation, prioritization, and meeting deadlines.
• Demonstrates strong project management skills.
• Maintains the ability to travel domestically and internationally as required by business needs.
• Demonstrates computer proficiency and data entry skills.
• Maintains knowledge of PV regulations, ICH guidelines, FDA safety regulations and submissions, EMA regulations, and the global pharmacovigilance regulatory environment.
• Demonstrates expertise in ICSR processing, clinical safety review, PV compliance, quality oversight, and vendor management.

Education/Experience:

• Education (Required): Health Care Professional degree, such as RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD.
• Experience (Preferred): Minimum 5–7 years of experience in a biopharmaceutical company with Pharmacovigilance responsibilities.
• Alternative Experience (Required): Equivalent clinical experience with a thorough understanding of FDA safety regulations and submissions, ICH guidelines, other applicable regulatory guidance documents, the global PV regulatory environment, and EMA regulations.
• Writing Experience (Required): Science/medical writing experience.
• Computer Skills (Required): Computer proficiency and data entry experience.
• Project Management (Required): Project management experience.