Enrique D. Miceli

Dynamic role in the field of pharmacovigilance. Key roles and responsibilities include project manager for data migration, compliance monitoring, and quality management

• Developing mapping documentation, ensuring accurate and a smooth transition of data from legacy databases to current pharmaceutical vigilance systems
• Training, mentoring and empowering team members
• Ensuring associates are well-equipped to handle a smooth transition into pharmaceutical vigilance systems and minimizing disruptions
• Adhering to strict timelines safeguarding the data migration process is completed efficiently
• Preventing unnecessary delays and enabling continuation of pharmaceutical vigilance oversight
• Established quality assurance protocols guarantee that information entered into pharmaceutical vigilance safety database meets the highest standards, reducing the risk of errors and ensuring data accuracy
• Adept at reconciling data discrepancies, ensuring that the migrated information aligns seamlessly with prior safety reporting
• Minimizes the likelihood of discrepancies and enhances data reliability
• Problem-solving prowess ensures that unexpected issues are addressed promptly and effectively, minimizing the impact on your operations
• Monitored compliance with safety information exchange agreements between the company and its partners
• Developed and implemented compliance monitoring processes and protocols to ensure adherence to regulatory requirements
• Conducted regular audits and assessments to evaluate partner compliance levels and identify areas of non-compliance
• Collaborated with cross-functional teams to address non-compliance issues and develop corrective action plans
• Coordinated with legal and pharmacovigilance agreement managers to ensure alignment with contractual obligations and industry regulations
• Initiate immediate communication with the partner to address concerns and identify reasons for non-compliance
• Prepared and presented compliance reports to senior management, highlighting key findings and recommendations for enhancements
• Escalate the matter to senior management and legal counsel if necessary to ensure swift resolution and uphold contractual agreements
• Investigated incidents of non-compliance and implemented corrective actions to address root causes
• Collaborate with internal teams to develop corrective action plans aimed at rectifying the non-compliance issues and preventing future occurrences
• Conducted risk assessments and gap analyses to identify potential compliance vulnerabilities and mitigate associated risks
• Established and maintained effective communication channels with partners to ensure timely and accurate information exchange
• Fostering transparency and trust in partnerships
• Point of contact during audits and inspections
• Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
• Provide subject matter expertise to process improvement initiatives
• As needed, utilize expertise in safety systems to investigate status of reports and perform searches in databases for reconciliation purposes, metrics etc
• Develop and maintain proficiency in work prioritization
• Assist with other projects, as requested by group management including traveling to India to interact with other functional groups (e.g., Training) to ensure adherence to processes and procedures
• Ensures compliance for cGMO policies and procedures for documentation resulting from manufacturing operations of clinical and commercial small molecule API and drug product
• Ensures corporate readiness towards regulatory CMC inspections
• Ensures data integrity in GMP documentation from manufacturing, analytical and stability studies
• Performs assessments and QA review of Change Controls, deviations, root cause analysis, and product impact assessments and investigations, including OOS investigations, for commercial and clinical products.

• Monitor electronic mailboxes and worklist for document requests
• Prioritize request based on case severity and established timelines
• Process requests by retrieving the necessary source documents from a data storage program, then processing them into global safety database
• Determining case validity and whether AE information is an initial report, follow-up, or a duplicate of an existing report
• Review case criteria to determine the appropriate workflow for case processing
• Review, rank, verify process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency
• Process cases based on these assessments
• Write and edit the case narrative
• Work effectively across therapeutic teams and functional groups
• Constantly apply regulatory requirements and policies
• E2B Workflow manager
• Monitor and assign cases to colleagues based on timeline and serious criteria
• Accept E2B cases received through the Argus Electronic submissions Module (ESM) as necessary and process prior to routing to next state
• Review processed cases to verify accuracy, consistency and compliance with process requirements and review case data for special scenarios
• Accurately entering AE data, including event seriousness, medical history, and laboratory data as provided by the reporter
• Coding medical terms and products specified as suspect or concomitant by the reporter
• Determine report ability of scheduled reports, ensuring adherence to regulatory requirements
• Distribute assessed and non-assessed reports to License Partners via E2B or through mailbox
• Monitor electronic mailboxes and Argus ESM to ensure timely acceptance of Adverse Event (AE) Reports.

• Entering existing document information into an electronic document management system
• Ensure documents are in compliance with standard operating procedures
• Conduct complex database searches
• Actively communicate with both in-house CRA and CRO to verify and correct study site documents
• Provide reports and information as requested by clients (Monitors, Investigators, and Sub-Investigators)
• Prepare CRF and TMF documents for FDA submission
• Aid in the training of new colleagues.