Clinical Medical Services Specialist III

Responsibilities

• Oversight of external vendors to ensure collection, assessment, and processing of post-marketing adverse event information is performed in a compliant and timely manner.
• Ensure appropriate assessment of adverse events, including seriousness, labeling, causality, and management of both initial and follow-up reports.
• Monitor vendor performance to confirm company standards for quality, compliance, and productivity are consistently met.
• Support vendor case quality metrics and productivity, promoting agile, accountable, and results-driven case management processes.
• Act as a liaison with Quality Assurance for product quality issues that involve adverse events, ensuring coordinated evaluation and resolution.
• Collaborate with Customer Service to provide standard medical information and arrange product replacement when appropriate.
• Provide assistance to healthcare professionals and the lay community using information from package inserts and standard letter databases, including labeled and certain off-label indications.
• Support and participate in internal and external audits and regulatory inspections as needed, providing documentation and subject matter expertise.
• Develop knowledge and expertise in vendor management to initiate mentoring of Medical Services Associates (MSAs).
• Contribute to the development of training materials and deliver training in conjunction with vendors, including train-the-trainer sessions, special-topic refreshers, and internal trainings.
• Demonstrate the ability to lead project work related to case processing, vendor oversight, and process improvement initiatives.
• Manage and prioritize multiple case-related tasks in a fast-paced environment while maintaining high attention to detail and compliance.
• Perform quality review and compliance checks on case processing activities to ensure adherence to internal procedures and external regulations.
• Collaborate effectively within cross-functional teams to resolve issues, share insights, and enhance overall case management performance.
• Carry out other duties as assigned based on organizational needs and evolving work requirements.

Requirements

• Active RN license with a BSN or equivalent nursing qualification, strongly preferred, with a solid clinical background.
• Hospital-based clinical experience in emergency room, intensive care unit, cardiac care, or critical care settings.
• PharmD candidates may be considered if they bring strong clinical and pharmacovigilance experience.
• Minimum of a bachelor’s degree in a life science discipline; RN, BSN, BS, BS Pharm, PharmD, or an advanced degree preferred.
• 2–4 years of clinical experience, or 2–3 years of clinical experience plus at least 1 year of pharmacovigilance experience.
• Demonstrated experience in post-marketing case processing of adverse events.
• Experience with vendor oversight or vendor management in a clinical or pharmacovigilance context.
• Hands-on experience performing quality review and compliance checks related to case processing or medical data.
• Core knowledge of industry regulations and guidelines, including ICH, FDA, EMEA, and MHRA requirements.
• Competence in case processing processes, procedures, and conventions within a pharmacovigilance or medical services environment.
• Demonstrated ability to lead project work and drive results in process management.
• Proven success in results-driven process management, with a focus on efficiency and compliance.
• Demonstrated ability to work collaboratively in a team environment and build effective cross-functional relationships.
• Strong understanding of the changing regulatory environment and its impact on case management processes.
• Strong written and verbal communication skills for interacting with healthcare professionals, internal teams, and vendors.
• High attention to detail and a strong compliance mindset, particularly in handling regulated medical information.
• Able to balance multiple priorities and manage workload effectively in a fast-paced setting.
• Experience supporting audits or inspections in a clinical, quality, or pharmacovigilance setting is a plus.

Essential Skills

• Advanced degree in a life science or healthcare-related field is preferred.
• Experience mentoring or coaching colleagues, particularly in vendor management or case processing activities.
• Experience contributing to or delivering training programs, including train-the-trainer sessions and topic-specific refreshers.
• Familiarity with standard medical information sources such as package inserts and standardized medical letter databases.
• Ability to interpret and communicate labeled and certain off-label information and indications in a clear, compliant manner.
• Demonstrated agility and accountability in managing complex workflows and timelines.
• Comfort working with cross-functional stakeholders such as Quality Assurance and Customer Service.
• Strong organizational skills and the ability to maintain accurate documentation in line with regulatory and company standards.
• Proactive approach to continuous learning and staying current with pharmacovigilance best practices and regulatory updates.