About Heidi Moubarak:
- Committed Regulatory Affairs and Pharmacovigilance (PV) Professional, with high attention to details, focused on meeting regulatory and PV standards and timelines.
- 5+ years of experience in both Pharmaceuticals and Medical Devices Regulatory and Pharmacovigilance activities.
- Excellent relation with government officials.
- Enthusiastic and skilled professional in the field of medical training, highly skilled in content development and creating learning programs and solutions to achieve education goals.
- Multilingual: English, Arabic, German, and French.
Experience
WORK EXPERIENCE
Schuelke and Meyr GmbH, Germany (based in UAE)
Regional Regulatory Affairs Manager – GCC
2020 - till date
- Act as a liaison between the global regulatory affairs team in Germany and the local agents in the different countries.
- Responsible for all communications with the regional agents to ensure all submissions are done accurately and in a timely manner.
- Review all the required documents for the different regulatory activities and share them with the agent.
- Provide guidance and advise on submission processes and timelines.
- Communicate any new guidelines/ circulars shared by the agents with the global team and advise on any necessary actions.
- Maintain a track record of all regulatory activities and archive all shared documents and issued certificates.
Pharmaworld LLC, UAE
Regulatory Affairs and Pharmacovigilance Manager
2017 - till date
- Lead the Regulatory and Pharmacovigilance department.
- Develop, implement, and maintain procedures in support of regulatory compliance.
- Assist in developing and documenting sound regulatory decisions and justifications and advise on the impact of changing regulations on the organization and on the principal companies.
- Responsible for timely application submissions on the MOHAP or Dubai Municipality Website
- Review labeling to ensure that all labeling is in accordance with local regulatory requirements.
- Ensure timely approvals by being in close contact with the health authority officials and constantly following up when necessary.
- Handle Quality Assurance by effectively reporting any quality-related cases to the principal companies as well as to the MOHAP when necessary.
- Perform RCA and CAPA
- Author and implement standard operating procedures (SOP’s), training materials and safety practices consistent with the requirements of the local regulatory authorities.
- Perform internal audits to ensure compliance with the company’s SOP’s.
- Guide and advise on PV and regulatory requirements within the organization as well as with our principals.
- Oversee Complaint Handling, Adverse Reaction/Event Reporting and Recalls.
- Create and facilitate Regulatory Affairs and Pharmacovigilance Training for new hires and trainees.
- Review and approve Regulatory, Pharmacovigilance, Compliance and Quality agreements.
Shoppers Drug Mart Patient Contact Centre, Canada
Patient Educator and Lead Training Facilitator
2014 - 2016
- Supported outbound calls to patients, provided patient education and medical information so that patients resume their interrupted chronic therapy when necessary.
- Provided clinical education and answered therapeutic questions in a time efficient manner.
- Provided organizational leadership to plan and implement strategic training and development opportunities.
- Evaluated organizational training requirements and worked with other team members to design solutions optimizing onboarding, employee performance and quality management.
- Created and facilitated the New Hire training program and the Pharmacy Assistant Training program.
- Coordinated over 40 training courses to deliver high quality trainings to 400+ participants.
Education
Pharmacy Examining Board of Canada- PEBC, Canada
Canadian Board Certification 2014
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