What are the responsibilities and job description for the Compliance Specialist, Customer Care position at DataSync?
Description
The Customer Care Compliance Specialist is responsible for pharmacovigilance case management and departmental documentation governance. This role ensures timely and compliant safety case handling, maintains accurate records and training completion tracking, and serves as the subject matter expert for adverse event and product complaint processes.
The Compliance Specialist works closely with the Training & Compliance Manager and supports audit readiness. This role owns departmental SOP governance, including drafting, maintaining, and coordinating documentation in alignment with regulatory expectations and client requirements.
Requirements
Essential Functions and Responsibilities
Pharmacovigilance Operations
Education
The Customer Care Compliance Specialist is responsible for pharmacovigilance case management and departmental documentation governance. This role ensures timely and compliant safety case handling, maintains accurate records and training completion tracking, and serves as the subject matter expert for adverse event and product complaint processes.
The Compliance Specialist works closely with the Training & Compliance Manager and supports audit readiness. This role owns departmental SOP governance, including drafting, maintaining, and coordinating documentation in alignment with regulatory expectations and client requirements.
Requirements
Essential Functions and Responsibilities
Pharmacovigilance Operations
- Monitor and manage incoming Adverse Event (AE) and Product Complaint (PC) cases within the case management system (Salesforce).
- Review case details for completeness, accuracy, and compliance with regulatory and client requirements.
- Prepare and submit AE reports to clients within established service level agreements (SLAs).
- Conduct monthly and quarterly AE audits, ensuring adherence to regulatory requirements, internal policies, and client requirements.
- Follow up with reporters, clients, or internal teams to obtain additional or clarifying information as needed.
- Maintain accurate documentation of case processing activities and ensure proper case records.
- Serve as the point of contact for pharmacovigilance-related inquiries from internal teams and clients.
- Participate in client meetings to provide updates on AE case management and operational status.
- Track case metrics and support efforts to maintain quality and timeliness standards.
- Assist with preparation for internal reviews, client audits, and regulatory inspections.
- Coordinate internal and client-specific PV training requirements across the department.
- Track and maintain PV training completion records to ensure compliance with internal policies and client obligations.
- Draft, review, and maintain departmental Standard Operating Procedures (SOPs), work instructions, and controlled documentation, ensuring accuracy and compliance while coordinating version control, review cycles, approvals, and archival.
- Ensure departmental documentation remains current with regulatory expectations, client requirements, and internal quality standards.
- Assist with preparation and maintenance of documentation for internal audits, client audits, and inspections as needed.
- Contribute to process improvement initiatives to enhance documentation quality and operational efficiency.
Education
- Bachelor’s degree or equivalent experience.
- 2 years of experience in customer care, healthcare operations, or a related field preferred.
- Experience with Salesforce is a plus.
- Experience with pharmacovigilance or adverse event case management preferred.
- Strong attention to detail and organizational skills.
- Ability to manage multiple priorities while meeting deadlines and SLAs.
- Excellent written and verbal communication skills.
- Proficiency in Microsoft Office and documentation management systems.