Melissa Bernal Email and Phone Number
Vicepresident of the Colombian Pharmacovigilance AssociationCo-chair Ecopharmacovigilance SIG ISoPAs an experienced Pharmacovigilance Specialist, I possess a strong working knowledge of FDA, Health Canada, and EMA regulations/guidelines with respect to clinical safety and GMP. With over five years of hands-on experience, I have maintained an efficient vigilance system in compliance with health regulations and quality management systems. I am a healthcare professional with a Master´s degree in epidemiology, and I have exceptional attention to detail and the ability to collaborate with internal and external stakeholders to ensure compliance.Throughout my career, I have demonstrated a proven ability to provide training and ongoing support, perform quality assurance and quality control for work delegated to global vendors, and address issues. I have authored and developed documents related to pharmaceutical and cannabis-based products for NCA marketing authorizations in different countries. I have also conducted post-market surveillance and managed adverse event reporting in compliance with current regulations.As a self-starter with excellent verbal and written communication skills, I am able to work independently and collaborate effectively with teams. I possess excellent conflict resolution skills and am highly organized, which allows me to effectively manage multiple tasks and projects simultaneously.
Brunswick Dermatology Center
View- Website:
- cleverleaves.com
- Employees:
- 212
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Clinical Research CoordinatorBrunswick Dermatology CenterFredericton, Nb, Ca
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Medical AdvisorClever Leaves Jan 2023 - Present• Planning and preparation of monographs, packaging leaflets, inserts, prescribing information or other drug information in accordance with regulatory requirements• Literature review, data interpretation, statistical analysis, and safety summaries for cannabis-based products• Quality control QC of regulatory and medical documents related to the company's pipeline. -
QppvPhv Latam Nov 2022 - Present• Case processing of SAEs and other events subject to regulatory reporting in accordance with SOPs and E2B standards within established milestones.• Quality control of safety documents developed by other stakeholders, such as patient narratives, causality assessments, and aggregate reports. -
Vice PresidentAsociación Colombiana De Farmacovigilancia Mar 2022 - Present -
Board MemberAsociación Colombiana De Farmacovigilancia Mar 2019 - May 2022 -
External ConsultantInstitute Of Pharmacovigilance Mar 2022 - Dec 2022CzechiaExternal consultant: Developing LATAM pharmacovigilance profiles as a Regulatory Intelligence Expert. -
Pharmacovigilance And Safety DirectorPharmetique Labs Apr 2019 - May 2022Bogotá D.C. Area, Colombia• Managed end-to-end case processing for more than 100 adverse events per month and product quality complaints, ensuring compliance with regulatory requirements and timelines.• Collaborated with cross-functional teams to drive process improvements and identify efficiency opportunities, resulting in a 30% increase in case processing efficiency.• Developed more than 1500 documents required for regulatory submission within the stablished timelines.• Contributed to the development and implementation of quality management systems and processes for different pharmaceutical products• Led recall activities and Implemented corrective and preventive actions when required• Development of SOPs for PV activities within the company• Conducted annual staff product safety training and new hire onboarding training -
Head Of PharmacovigilancePharmetique Labs Mar 2017 - Apr 2019Bogotá D.C., Colombia• Received, analyzed and managed adverse events, adverse reactions, and other events notifiable to regulatory agencies in accordance with standard operating procedures within the time frame established for this purpose.• Performed pharmacovigilance activities in accordance with the company's quality management system.• Performed Risk Management Plans and Periodic Safety Update Reports (PSUR) for new and previously marketed molecules in the company for regulatory submission• Verificated pharmacovigilance processes according to local regulations in the 12 countries where the business relationships are established by managing queries, requests, complaints, and other issues of medical interest for internal and external customers.• Created and implemented the pharmacovigilance program for the companies: Pharmetique Labs, Bionutrec S.A.S. and La Vital S.A.S. -
Head Of PharmacovigilanceBionutrec Sep 2017 - May 2022As head of Pharmacovigilance, I started the vigilance program for probiotics ensuring that our products are safe for human use.
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Head Of PharmacovigilanceLa Vital Jan 2018 - Jul 2020
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Clinical Safety ScientistMsd Jun 2015 - Feb 2017ColombiaThe Clinical Safety Scientist (CSS) is the experienced resource in charge of safety reporting process for Serious Adverse Experiences (SAE), Events of Clinical Interest (ECI), other reportable events, Company Causality Assessments and medical review from global clinical trials. Under the direction of the Associate Manager/Manager/Director the CSS will be responsible for receiving, reviewing, managing and creating case reports for all the reportable events according to standard operating procedures for further reporting to Global Safety within the established time frames. In addition, the CSS should collaborate with colleagues within the organization as well as cross-functionally, to participate or lead technical and/or process improvement projects. -
Medical Doctor - AuriculotherapyNatural Body Center Ips Jul 2012 - May 2015BogotaOutpatient Medical doctor working in alternative medicine with auriculotherapy and management of healthy habits related with metabolism and chronic diseases.
Melissa Bernal Skills
Melissa Bernal Education Details
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Post-Graduate Program -
Translational Medicine -
Universidad Del Rosario - Universidad CesEpidemiology -
Metabolism, Biological Drugs And Auriculomedicine -
Medicine
Frequently Asked Questions about Melissa Bernal
What company does Melissa Bernal work for?
Melissa Bernal works for Brunswick Dermatology Center
What is Melissa Bernal's role at the current company?
Melissa Bernal's current role is Clinical Research Coordinator.
What schools did Melissa Bernal attend?
Melissa Bernal attended Harvard T.h. Chan School Of Public Health, Universidad Del Rosario, Universidad Del Rosario - Universidad Ces, Universidad Del Rosario, Universidad Del Rosario.
What are some of Melissa Bernal's interests?
Melissa Bernal has interest in Economic Empowerment, Politics, Environment, Science And Technology, Disaster And Humanitarian Relief, Human Rights, Animal Welfare, Arts And Culture, Health.
What skills is Melissa Bernal known for?
Melissa Bernal has skills like Clinical Trials, Terapia, Medicina Interna, Epidemiology, Farmacovigilancia, Cpr Certified, Clinical Research, Medicina, Regulatory Affairs, Healthcare, Standard Operating Procedure, U.s. Food And Drug Administration.
Who are Melissa Bernal's colleagues?
Melissa Bernal's colleagues are Miryam Lorena Malaver Fonseca, Yovanna Alexandra Fuentes Montaña, Lázaro Grisales Restrepo, Paula Andrea Zamora Castro, Irene Herrera, Yesi Henao, Maurice Thadd.
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Melissa Ekanem
Results-Driven Strategist: Transforming Strategic Plans Into Quantifiable Success Through High-Performing TeamsRaleigh, Nc -
Melissa Bernal
Design & Content Manager | Social Media & Content Creator | Photographer | Digital Marketing, Analytics & E-Mail Marketing Specialist | Website SpecialistAtlanta, Ga -
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