Senior Post Marketing Study Lead

Pay range: 50-60/hr

• depending on experience The Senior Post Marketing Study Lead plays a crucial role in ensuring the effective and compliant collection, safety assessment, processing, and reporting of adverse event (AE) data in line with global regulations and Pharmaceuticals' procedures.

This role may involve supporting accurate data entry, facilitating smooth workflows, and timely reporting of AEs to regulatory authorities. The Senior Post Marketing Study Lead will participate in safety management, manage adverse event workflows, and support policy and SOP development. The PM Study Lead will participate in post marketing study-related and safety management activities, including, but not limited to Protocol review, SAE reconciliation, data listing and coding review, and configuration of studies. Additionally, they may contribute to special projects as assigned by Pharmacovigilance Operations (PV Ops) management.

Case Processing and Safety Data Management:

• Maintain high-quality, timely review, coding, data entry, and quality assurance of post-marketing cases in the Global Safety Database, ensuring adherence to standards and regulatory requirements.
• Coordinate with internal stakeholders to align case processing standards with regulatory needs and business objectives, such as risk management, aggregate data analysis, and safety reporting.
• Manage queries from Business Partners.

Experience with Configuration and UAT testing

Vendor and Compliance Oversight:

• Manage and oversee pharmacovigilance activities performed by vendors, ensuring that all practices are consistent and compliant with regulatory standards.
• Provide comprehensive support and training to vendors involved in pharmacovigilance, including: o Quality Control (QC) evaluations and issue management. o Case management activities o Literature surveillance o Reconciliation activities
• Ensure compliance with reporting standards and global safety regulations.

Operational Management and Process Improvement:

• Support the setup, maintenance, and enhancement of adverse event workflows and systems.
• Protocol review, initiation and testing of configurations of Post Marketing studies, IST, etc.
• Identify opportunities to improve processes through internal/external insights, regulatory updates, and best practices in pharmacovigilance.

Safety Information and Labeling Support:

• Oversee day-to-day ICSR activities with vendors, ensuring data accuracy, completeness, and regulatory compliance.
• Act as an expert resource for system configuration, database queries, and system testing to support safety data management needs.

Regulatory Reporting and Project Leadership:

• Lead the preparation of safety-related plans with internal and external partners to ensure consistent, compliant safety reporting across all studies.
• Contribute to safety-related sections of study reports, annual safety updates, and expedited reports for global regulatory submissions.
• Respond to safety-related queries from Regulatory Authorities or Ethics Committees and manage deviation and CAPA activities for case management.

Training, Mentorship, and Team Collaboration:

• Provide study specific case processing training, training materials, and guidance for vendors and cross-functional teams.
• Mentor PV Operations team members and support team operations and workflow coordination as needed.

Cross-Functional and Inspection-Readiness Collaboration:

• Serve as a PV liaison to post marketing teams supporting post marketing study activities (IST, COOP, RWE) including protocol review, SMP if required, reconciliation, and support of aggregate reports.
• Collaborate with

GRADS AM, GRADS

Compliance, R D Quality, and Clinical teams to monitor performance, resolve bottlenecks, and reduce regulatory risk in adverse event management.

• Provide appropriate representation during PV related regulatory inspections or internal quality assurance compliance audits. Essential Functions/Responsibilities
• Collaborates with other members of case management and other operations groups to ensure critical or missing case information for appropriate medical assessment is obtained.
• Follow company templates and GxP guidelines for documentation and communications, ensuring accuracy and compliance.
• Ensure adherence to corporate and departmental policies, SOPs, and timely completion of all assigned training.
• Ensures compliance and quality are maintained and issues are escalated appropriately and resolved.
• Support PV Operations Team with various tasks as needed.
• Developing study specific training materials with case processing nuances and provide detailed training to case management vendor when introducing new or updated study information.
• Contribute to developing adverse event case management workflows and training materials when introducing new or updated processes.
• Assist in coordinating department workflows and participate in special projects as directed by department management.
• Serve as an individual contributor or project manager for functional projects or workflows.
• Mentor other team members, including service providers, to build team capability.
• Participate in inspections and audits as required, ensuring an inspection-ready operational state.
• Take responsibility for personal development, staying updated on pharmacovigilance practices, regulations, and guidelines.
• Collaborate with

GRADS AM, GRADS

Compliance, PV Ops, R D Quality, and Clinical teams to assess performance, identify bottlenecks, reduce regulatory risks, and improve adverse event management processes.

• Act as team lead in the absence of the manager, assuming key responsibilities as needed. Required Knowledge, Skills, and Abilities
• 10+ years of pharmaceutical drug safety/pharmacovigilance experience.
• Experience with quality management systems (e.g., document management, learning management, change control).
• Comprehensive knowledge of FDA and international regulations related to AE and ICSR requirements, with the ability to interpret and apply these regulations.
• Proven ability to collect, analyze, disseminate, and report safety information in compliance with global regulations.
• Proficiency in standard desktop software (Word, Excel, Outlook).
• Proficient with safety database applications.
• Experience using MedDRA and MedDRA coding.
• Strong understanding of medical terminology and ability to summarize medical information.
• Excellent oral and written communication skills.
• Highly organized with strong attention to detail.
• Demonstrated accountability for results, problem-solving, and decision-making abilities.
• Strong time management, prioritization, and planning skills, with the ability to work under strict timelines.
• Quality-oriented mindset with attention to detail.
• Ability to adhere to established processes and adapt to new priorities, demonstrating a continuous improvement mindset.
• Ability to work collaboratively within a team in a dynamic, fast-paced environment.
• Flexibility to work outside normal hours or on-call as needed. Required/Preferred Education and Licenses
• BS/BA degree in health-related or biological science-related field required