Lida Y. Ramirez Reatiga

• Assessment of protocols and support implementation and application of Integra IT software for specific electronic CRF, electronic Clinical Outcome Assessment / electronic Patient Report Outcome in clinical trial
• Assist with medical and clinical oversight of all aspects of function and work performed within Integra IT software development
• Participates in review of source data and/or data listings of safety data, laboratory data, and vital signs data to establish presence or absence of abnormal trends
• Establish working relationships with client representatives and Provide support for marketing activities as requested.

Achievements: Decreased analysis time for the implementation of protocols from 1 week to 1 business day.

Increase in the generation of leads, implementing efficient strategies.

• Oversee and manage operations on regional level (LATAM) and support management of operational processes in compliance with internal procedures, Customers’ procedures, global and national pharmacovigilance regulations, standards, and guidelines.
• Meet local legislative requirements in maintenance of local pharmacovigilance system and ensure Regulatory Intelligence process is in place.
• Deliver pharmacovigilance training to Customers’ personnel in /her territory, when required.
• Ensuring always audit/inspection readiness.

Achievements:

• Established and maintained operational standards for Peru and Colombia locations.
• Modernized educational Pharmacovigilance material for PV and company employees.
• Cero (0) critical findings in audits.

Oversee and manage operations on local level and support management of operational processes in compliance with internal procedures, Customers’ procedures, global and national pharmacovigilance regulations, standards, and guidelines. Interact and exchange relevant safety information with local Competent Authorities. Meet local legislative requirements in maintenance of local pharmacovigilance system and ensure Regulatory Intelligence process is in place.

Deliver pharmacovigilance training to Customers’ personnel in /her territory, when required.

Achievements:

• Improvement and update Regulatory Intelligence process.
• Cero (0) findings in internal audits.

Respond to inquiries via phone or email from healthcare professionals,
consumers, and patients managing adverse events, product quality
complaints, HCP, and patient education.
Primary responsibility will be to answer inbound calls from health care
providers and patients about medications and communicate complex
medical information.
Provide in-depth information and specific product prescribing
information, clinical studies, and medical letters.
Adhered to good clinical practices, operating procedures, and regulatory
requirements.

Achievements:

• Identified issues, analyzed information and provided solutions to problems
• Developed strong communication and organizational skills through working on group projects

• Physician training on pharmacovigilance in phase II and III clinical studies.
• Experience as contact between pharmaceutical industry and clinical researchers and between pharmacological laboratories and experts in clinical and research fields.
• Participation in review of study data and/or data lists, including adverse effects, laboratory data, and vital signs to establish presence or absence of abnormal trends, and follow-up as appropriate with clinical team.
• Assist with training and input in performance assessments for clinical operations staff. Work directly with clinical operations staff in reviewing laboratory data, and medical histories and evaluating inclusion/exclusion criteria for study participants.

Achievement:

Medical supervision of all aspects of clinical trial for two global studies of 3000 patients each.

• Participation in t review and coding of adverse events and concomitant medicinal products to ensure accuracy and consistency of data.
• Provide support for preparation of clinical protocol and ls, clinical, and statistical reports.
• Participation in review of individual adverse effects reports considering accuracy and clinical importance and characterizing their relationship with drug under study or post-marketing medicines.
• Review and writing of PSURs.

Achievements:

Improvements of processes and work flow that increased the efficiency of processing of ICSR (75%).