Daniela Montenegro Mendez
San Jose
Summary
Hardworking Safety Officer, experienced in field and ready for challenging assignments. Reliable in completing quality work and exceeding expectations. Highly-motivated employee with desire to take on new challenges. Strong worth ethic, adaptability and good interpersonal skills. Adept at working effectively unsupervised and quickly mastering new skills.
Overview
9
9
years of professional experience
Work History
Safety Officer
Pfizer
Escazú, San Jose
01.2019 - Current
- Carry out all case management activities as appropriate.
- Ensure regulatory compliance with timelines for individual expedited case report submissions and timely delivery of information for aggregate reports and other regulatory documents as requested.
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.
- Ensure complete and timely forwarding of ICSR to Core.
- Determine if appropriate case follow-up has been considered. Conduct follow-up activities when needed.
- Consistently apply regulatory requirements and Pfizer policies.
- Analyze and monitor activities, define and implement corrective actions, where applicable.
- Develop and maintain expertise of all assigned products, of applicable corporate policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.
- Provide oversight and team mentoring on case handling aspects, data extraction and analyses.
- Manage, where applicable, safety resources in the local team.
- Leverage and apply required judgment, issue resolution and negotiation skill-sets necessary to play a leadership role as a subject matter expert and/or project lead across the GPO DSU organization
- Act as subject matter expert for the DSU within WWS.
- Act as subject matter expert for suppliers and stakeholders, locally, concerning safety-related issues; and, liaise with key partners (e.g., BUs, License Partners) regarding safety data collection and handling.
- Promote/participate, as appropriate, in local, internal and external safety activities.
- Provided leadership during times of organizational change or crisis situations.
- Coached, mentored and trained team members in order to improve their job performance.
- Recruited and hired qualified candidates to fill open positions.
- Led team meetings and one-on-one coaching sessions to continuously improve performance.
- Conducted performance evaluations, providing feedback and coaching for team development.
Central Medical Reviewer (secondment)
Pfizer
Escazú, Costa Rica
09.2023 - 06.2024
- Medical review for promotional and non promotional materials of several therapeutic areas globally, based on internal policies and external regulatory guidance.
- Continous training to keep updated knowledge about changes related to assigned products.
- Identified potential discrepancies between submitted claims and supporting documentation.
- Delivered assigned materials withing appropiate timelines.
Safety Data Management Specialist,
Pfizer
Escazú, San Jose
03.2017 - 12.2018
- Perform case processing activities (Book in, Data Entry and Peer Review of cases).
- Review case criteria to determine appropriate workflow for case processing.
- Assess cases to distinguish those with complexities and/or specific issues, and escalate appropriately.
- 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.
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios.
- Completion of action items (Case closure, NCS Notification, set up OMN (Other Manufacturing Notification) action items).
- Determine and perform appropriate case follow-up, including generation of follow-up requests.
Regulatory Affairs Officer, Pfizer (Labelling and
Pfizer
Escazú, San Jose
08.2016 - 02.2017
- Management of monograph and insert updates for GEP product line in Central America and the Caribbean.
- Review of changes impacting primary and secondary packaging for GEP product line in Central America and the Caribbean.
- Knowledge of local policies in order to ensure submissions within challenging timelines in multiple countries and enforce regulatory affairs department compliance with agency requirements.
- Thorough reviews of monographs and inserts of various drugs against the core data sheet to ensure that the changes submitted are approved under the current regulations of the country.
Regulatory Affairs Trainee
AstraZeneca
Escazú, San Jose
01.2016 - 07.2016
- Elaboration of renewal dossiers for drugs products in Central America and Caribe.
- Artwork review of drug products for Central America, Caribe, Ecuador and Perú.
- Management and use of company databases.
- Elaboration of post registration changes dossiers for drugs products in Central America and Caribe
Education
Pharmacy - Bachelor's Degree
Universidad De Costa Rica
EscapeEscapeEscapeEscapeSan Jose08.2016
Bachelor of Arts - Classical Philology
Universidad De Costa Rica
San JoseSkills
- Compliance reporting
- Leadership techniques
- Medical terminology
- Time Management
- Interpersonal communication
- Training and Development
- Efficient information review
- Verbal and written communication
- Staff Management
Additional Information
Trainings/Meetings/Conferences
Evaluation of Benefit-Risk of medicines-2021 -Josué Bautista Arteaga Farmacovigilancia, Online Training
Business Leadership- 2020-Instituto Tecnológico de Costa Rica.
Diploma in Leadership, Strategy and development and new trends-2018-Universidad Politécnica de Valencia, Online Training
Languages
Spanish
Native/ Bilingual
English
Native/ Bilingual
French
Professional
Portuguese
Professional
Japanese
Elementary
Timeline
Central Medical Reviewer (secondment)
Pfizer
09.2023 - 06.2024
Safety Officer
Pfizer
01.2019 - Current
Safety Data Management Specialist,
Pfizer
03.2017 - 12.2018
Regulatory Affairs Officer, Pfizer (Labelling and
Pfizer
08.2016 - 02.2017
Regulatory Affairs Trainee
AstraZeneca
01.2016 - 07.2016
Pharmacy - Bachelor's Degree
Universidad De Costa Rica
Bachelor of Arts - Classical Philology
Universidad De Costa Rica