Sr. Pharmacovigilance (PV) Clinical Scientist

About the role

The Sr. Pharmacovigilance (PV) Clinical Scientist within the US Patient Safety PV Compliance Team plays a critical role in the clinical review, evaluation, and processing of adverse event information. This position leads the clinical review of cases processed in-house and by external vendors, ensures high-quality Individual Case Safety Reports and Health Authority submissions, and supports PV leadership in maintaining compliance with global pharmacovigilance regulations and internal standard operating procedures.

Responsibilities

• Perform timely, thorough, and accurate drug safety monitoring and tracking in accordance with pharmacovigilance standards, regulations, and internal standard operating procedures.
• Review, evaluate, and verify potential adverse event information during triage to determine required actions and complete data entry of adverse events in the global safety database.
• Conduct medical assessment of cases, including seriousness, validity, and causality, and perform quality review of all cases as applicable.
• Perform labeling assessments for adverse events using clinical knowledge and conduct follow-up for all reported cases as appropriate.
• Maintain thorough knowledge of Individual Case Safety Report requirements for assigned therapeutic areas.
• Perform trend analysis of vendor case processing issues for assigned therapeutic areas and escalate concerns to vendor leads and US Patient Safety management as needed.
• Update and create standard operating procedures and lead process improvement initiatives to enhance case processing and compliance.
• Develop executive summaries on quality trends observed on a quarterly basis and present key findings to stakeholders.
• Ensure the quality of Health Authority submissions meets local regulatory requirements.
• Lead clinical review of cases processed in-house and by vendors to ensure accuracy, completeness, and compliance.
• Analyze case processing data to evaluate error rates and identify potential compliance impacts, recommending corrective actions where necessary.
• Train internal US Patient Safety staff and vendor teams on pharmacovigilance processes and ensure ongoing PV compliance.
• Collaborate with internal departments and external partners on drug safety data exchange to support seamless and compliant information flow.
• Ensure appropriate data correction in the safety database for identified issues or errors and monitor the effectiveness of corrective actions.
• Maintain and update follow-up templates and ensure successful transmission of all follow-up attempts via the correspondence module.
• Train internal and external staff on using the correspondence module and perform reconciliation of outgoing communications.
• Maintain robust knowledge of Technical Product Complaints and Medical Product Complaints for all company products, including combination products.
• Ensure all product complaints are reported to appropriate stakeholders within defined timelines.
• Perform due diligence to obtain missing or additional information for adverse events in accordance with company procedures and local and global regulations.
• Escalate issues related to follow-up activities and provide strategic resolutions to US Patient Safety management.
• Aid US Patient Safety management in maintaining oversight of Good Pharmacovigilance Practice vendors.
• Identify risks and gaps related to case processing for GVP vendors and propose mitigation strategies.
• Continuously monitor feedback from stakeholders and vendors to inform quality improvements and process updates.
• Prepare and develop Patient Safety presentations and participate in internal and external education for stakeholders and vendors.
• Serve as a Subject Matter Expert for safety-related activities within the global safety database and ensure adherence to relevant standard operating procedures.
• Provide support during audits and inspections, including preparation of documentation and responses to findings.
• Collaborate with other patient safety teams as needed to ensure alignment and consistency in safety processes and practices.
• Lead assigned projects under the direction of US Patient Safety PV Clinical management, ensuring delivery on time and in line with quality expectations.
• Prepare and develop Patient Safety presentations and participate in internal and external education for stakeholders and vendors.
• Serve as a Subject Matter Expert for safety-related activities within the global safety database and ensure adherence to relevant standard operating procedures.
• Provide support during audits and inspections, including preparation of documentation and responses to findings.
• Collaborate with other patient safety teams as needed to ensure alignment and consistency in safety processes and practices.
• Lead assigned projects under the direction of US Patient Safety PV Clinical management, ensuring delivery on time and in line with quality expectations.

Qualifications

• Health care professional degree such as RN, BSN, MSN, NP, RPh, B Pharm, Pharm D, or MD.
• Minimum 5 to 7 years of experience in a biopharmaceutical company with pharmacovigilance responsibilities, or equivalent clinical experience.
• Thorough understanding of FDA safety regulations, ICH guidelines, EMA regulations, and the global pharmacovigilance regulatory environment.
• Demonstrated ability to comprehend and interpret complex medical information.
• Strong ownership, initiative, and accountability in managing pharmacovigilance activities.
• Sound decision-making abilities, including systematic gathering of information, assessment of issue complexity, and effective prioritization of tasks.
• Dynamic leadership skills with the ability to guide projects and coach colleagues with less experience.
• Ability to work independently with minimal supervision and to collaborate effectively within cross-functional teams and with external partners.
• Ability to exercise independent judgment and discretion in matters of significance related to patient safety and compliance.
• Highly effective communication and presentation skills, with the ability to summarize and present key considerations and decision points to diverse audiences.
• Strong attention to detail in reviewing cases, establishing priorities, and meeting deadlines.
• Prominent project management skills to plan, execute, and monitor pharmacovigilance and compliance initiatives.
• Science or medical writing experience, including preparation of summaries, presentations, and training materials.
• Computer proficiency and accurate data entry skills for working within global safety databases and related systems.
• Ability to travel domestically and internationally based on business needs.

Additional Skills & Qualifications

• Experience working in a biopharmaceutical environment with direct pharmacovigilance responsibilities is preferred.
• Familiarity with global safety databases and related pharmacovigilance systems.
• Experience with Good Pharmacovigilance Practice vendor oversight and quality management.
• Experience developing and updating standard operating procedures and process documentation.
• Experience leading process improvement initiatives and implementing changes based on regulatory or procedural updates.
• Experience conducting trend analyses and preparing executive summaries on quality and compliance metrics.
• Experience supporting audits and inspections in a regulated environment.
• Ability to thrive in an agile, fast-changing environment and adapt quickly to new requirements.
• Strong collaboration skills for working with internal teams, vendors, and external partners.
• Experience in training internal and external stakeholders on pharmacovigilance processes, systems, and correspondence modules.