Clinical Medical Services Specialist III

Clinical Medical Services Specialist III

The Clinical Medical Services Specialist III provides advanced medical support focused on the intake and evaluation of medical product experiences, with a strong emphasis on post-marketing adverse event case processing and vendor oversight. This role ensures that adverse event information is assessed, processed, and reported in a compliant and timely manner in alignment with global pharmacovigilance regulations. The specialist acts as a key liaison across Quality Assurance and Customer Service, supports audits and inspections, contributes to training and mentoring activities, and helps maintain high standards of quality, productivity, and regulatory compliance in case management processes.

Responsibilities

• Conduct 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.
• Remain current on knowledge and skills required for case processing, pharmacovigilance practices, and evolving regulatory expectations.
• 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.
• Apply a strong understanding of pharmacovigilance processes, workflows, and global regulatory requirements to daily case management activities.
• Perform quality review and compliance checks on case processing activities to ensure adherence to internal procedures and external regulations.
• Support continuous improvement of case processing procedures, conventions, and documentation standards.
• 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.

Essential Skills

• 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.
• 24 years of clinical experience, or 23 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.
• Ability 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.

Additional Skills & Qualifications

• 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.

Work Environment

This position operates in a 100% remote work environment, offering flexibility while maintaining high standards of professionalism and accountability. Work is primarily computer-based, involving electronic case processing systems, documentation tools, and communication platforms for collaboration with internal teams, vendors, and external stakeholders. The role supports a fast-paced, results-oriented culture that values clear communication, attention to detail, and adherence to global regulatory requirements. Team members participate in virtual meetings, panel interviews, and remote audits or inspections as needed. Typical business hours are followed, with the expectation of managing multiple priorities and deadlines in a structured yet dynamic setting. Dress code is generally business casual for virtual interactions, with a focus on maintaining a professional presence in all communications.

Job Type & Location

This is a Contract position based out of North Chicago, IL.

Pay and Benefits

The pay range for this position is $39.00 - $43.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Jul 8, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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