Hedaiah Tolbah
Raleigh,NC
Summary
Pharmaceutical professional with over 7 years of expertise in medical information, pharmacovigilance, and quality review. Skilled in evaluating medical and safety documentation for accuracy and compliance with regulatory standards. Demonstrated success in cross-functional collaboration, risk identification, and process improvement. Aiming to leverage this experience in pharmaceutical advertising, promotional review, medical information management or regulatory coordination.
Overview
3
3
Languages
1
1
Certification
11
11
years of professional experience
Work History
Senior Medical Information Specialist
RiconPharma, LLC
Denville, USA
01.2024 - Current
- Supported Medical Information Center operations by ensuring accurate, consistent, compliant, and timely responses to healthcare professionals, patients, and internal stakeholders.
- Review medical information and safety documentation for accuracy, completeness, consistency, and compliance before case processing.
- Evaluate incoming inquiries to identify, document, and escalate adverse events and product quality complaints in accordance with pharmacovigilance requirements and company procedures.
- Prepare and review FDA MedWatch documentation, ensuring reportable safety and product-quality information is accurately and completely captured.
- Apply MedDRA coding to support accurate safety-case documentation and regulatory reporting.
- Prepare and review initial and follow-up documentation for adverse events, product quality complaints, and medical information inquiries.
- Perform safety reconciliations to confirm that reportable information is accurately captured and tracked across medical information and pharmacovigilance systems.
- Coordinate medical information activities with Medical Affairs, Regulatory Affairs, Pharmacovigilance, and Quality.
- Identified documentation trends, quality concerns, and process gaps; recommended improvements that strengthened compliance and reporting quality.
- Monitored quality trends and contributed to continuous improvement initiatives that enhanced Medical Information Center operations.
- Ensure activities and documentation comply with company SOPs, approved processes, and applicable regulatory requirements.
Senior Medical Information Associate
PrimeVigilance
Raleigh, USA
04.2022 - 12.2023
- Served as primary client contact for resource planning, budgeting, change management, training, and operational support, ensuring alignment with client needs.
- Managed 13 client programs by addressing operational concerns and ensuring consistent delivery of medical information and pharmacovigilance services.
- Acted as project lead for three client accounts, coordinating monthly invoicing, procedures, resources, and program requirements.
- Managed the collection, documentation, and processing of adverse events, product quality complaints, patient-support inquiries, and medical information requests.
- Assessed quality, accuracy, and compliance of call and case documentation against client-specific procedures and SOPs to uphold service standards.
- Identified quality trends and provided feedback to improve call handling, documentation, and service delivery.
- Developed and delivered onboarding and continuing-training programs for new and existing team members.
- Collaborated with internal teams and client stakeholders to implement procedural changes and maintain program compliance.
Pharmacovigilance Case Manager II
PrimeVigilance
Raleigh, USA
03.2020 - 04.2022
- Managed the intake, assessment, and documentation of adverse events and product quality complaints across multiple client programs.
- Supported diverse pharmaceutical product portfolios across multiple therapeutic areas by responding to medical inquiries, documenting adverse events and product complaints, conducting follow-up, and communicating directly with healthcare professionals and patients.
- Identified adverse events, special situations, medication errors, and product quality complaints during medical information interactions and routed them through the appropriate reporting channels.
- Reviewed safety information for completeness, consistency, and required escalation in accordance with client procedures and pharmacovigilance requirements.
- Conducted follow-up outreach to patients, healthcare professionals, pharmacies, and other reporters to ensure comprehensive and accurate case information.
- Prepared clear and accurate case narratives based on information provided by consumers and healthcare professionals.
- Maintained quality and compliance by adhering to approved scripts, SOPs, client-specific procedures, and reporting timelines.
- Collaborated with quality, medical information, and pharmacovigilance teams to address documentation discrepancies and streamline case processing.
- Identified workflow and documentation issues, recommending targeted solutions to enhance case quality and operational efficiency.
Medical Information Associate I
PPD
Morrisville, USA
01.2019 - 03.2020
- Responded to medical inquiries via telephone and online channels, utilizing approved response documents and client resources to ensure accurate information delivery.
- Provided medical information and safety support for a global pharmaceutical client’s portfolio across multiple therapeutic areas, including direct engagement with healthcare professionals and patients.
- Researched and communicated accurate, balanced, and nonpromotional medical and product information to healthcare professionals, patients, and other requestors.
- Documented inquiries, research, and responses accurately in accordance with company procedures, project guidelines, and client requirements.
- Identified and routed adverse events, product quality complaints, medication errors, and other reportable information through appropriate channels to facilitate regulatory compliance.
- Reviewed inquiry details for completeness and conducted follow-up outreach to gather further information.
- Maintained up-to-date knowledge of client products, prescribing information, SOPs, protocols, and applicable regulations to support informed decision-making and inquiry responses.
- Delivered professional, patient-focused service while handling medically sensitive and time-sensitive inquiries.
Pharmacy Technician
CVS Health
Morrisville, USA
12.2016 - 05.2018
- Accurately processed and dispensed prescriptions while communicating medication, insurance, and order information to patients.
- Resolved insurance-processing issues and collaborated with pharmacists to ensure accurate and timely prescription fulfillment.
- Facilitated communication among patients, customer service representatives, warehouse personnel, and wholesalers to streamline prescription processes.
- Monitored inventory transactions and medication stock to maintain compliance with established procedures.
Pharmacy Technician
Morrisville Pharmacy and Compounding
Morrisville, USA
08.2015 - 01.2017
- Assisted pharmacists in efficiently processing prescriptions and delivering responsive service to patients via telephone and in person.
- Facilitated resolution of patients’ medication and treatment-related inquiries by promptly escalating questions to the pharmacist for appropriate counseling.
- Retrieved, counted, measured, packaged, and labeled medications under pharmacist supervision.
- Processed sales transactions, managed the cash register, and submitted insurance claims.
Education
Bachelor of Science - Public Health
University of North Carolina At Greensboro
Greensboro, NCAssociate of Arts -
Wake Technical Community College
Raleigh, NCSkills
- FDA MedWatch Documentation
- Adverse event intake
- MedDRA terminology
- SOP Compliance
- Quality Control and Compliance
- Safety Reconciliation
- Scientific communications
- MedDRA operations
- Process Improvement
- Project Management
- Cross-Functional Collaboration
- Stakeholder Engagement
- Team Development
- Microsoft Word
- Excel
- PowerPoint
- Outlook
- SharePoint
- IRMS
- LifeSphere
- Salesforce
- Content regulation
- MedDRA
Certification
- HIPAA Awareness for Business Associates
Languages
Arabic
Full Professional
English
Native/ Bilingual
American Sign Language
Professional
Timeline
Senior Medical Information Specialist
RiconPharma, LLC
01.2024 - Current
Senior Medical Information Associate
PrimeVigilance
04.2022 - 12.2023
Pharmacovigilance Case Manager II
PrimeVigilance
03.2020 - 04.2022
Medical Information Associate I
PPD
01.2019 - 03.2020
Pharmacy Technician
CVS Health
12.2016 - 05.2018
Pharmacy Technician
Morrisville Pharmacy and Compounding
08.2015 - 01.2017
Bachelor of Science - Public Health
University of North Carolina At Greensboro
Associate of Arts -
Wake Technical Community College