Isela Ramirez
Mexico City
Summary
Pharmaceutical Engineer with a strong background in Pharmacovigilance. Graduated from Instituto Politecnico Nacional. Currently working as a Pharmacovigilance Coordinator in a Clinical Research Organization in the Latin America Team and the Pharmacovigilance Global Translations Team as a valuable team member. Known for successfully working under pressure, supported by advanced English knowledge and deep understanding of regulations and industry standards. Experienced in managing medical information and consistently delivering high-quality results using effective management systems and databases.
Overview
1
1
year of professional experience
Work History
Pharmacovigilance Coordinator Associate II
Thermo Fisher Scientific
05.2024 - Current
- Provide contracted project coordination and safety support on programs with an emphasis on serious and non-serious adverse events.
- Liaise with internal functional team members to implement projects, coordinate and facilitate meetings and manage all incoming safety documentation.
- Coordinate the collection and processing of protocol inquiries, adverse events, diagnostics, and track all necessary data.
- Manage project specific training and their setup, maintenance of program files ensuring the programs remain audit ready, and engage in audits ensuring the compliance with all requirements.
- Manage project specific timelines ensuring successful completion is adhered to timelines.
- Perform data entry into internal or external databases, tracking systems and perform system reconciliations to identify issues which impact on project timelines.
- Supervise the maintenance of databases, ensuring that the documentation is aligned with the company standards.
- As part of the PV Translations team, assure that the translated documents and Certificate of Translations are delivered in a timely manner, protecting the patient's information according to Standard Operating Procedures, and resolving queries within the client and the Language Services Team.
- Keep knowledge up to date of industry regulations, ensuring compliance with all relevant policies and procedures.
Education
Pharmaceutical Engineer -
Instituto Politécnico Nacional
UPIBI07.2023
Skills
- Work under pressure
- Leadership
- Regulatory compliance
- Problem solving
- Communication skills
- Adaptability
- Teamwork
- Ability to multitask
- Time management
- Microsoft Office 365
- Databases
Languages
Spanish
Bilingual or Proficient (C2)
English
Bilingual or Proficient (C2)
German
Beginner (A1)
French
Elementary (A2)
Timeline
Pharmacovigilance Coordinator Associate II
Thermo Fisher Scientific
05.2024 - Current
Pharmaceutical Engineer -
Instituto Politécnico Nacional
Similar Profiles
Emily RobinsonEmily Robinson
Pharmacy Technician II at Fisher Bioservices, Thermo Fisher ScientificPharmacy Technician II at Fisher Bioservices, Thermo Fisher Scientific
Jennifer VangJennifer Vang
Inventory Coordinator at Thermo fisher ScientificInventory Coordinator at Thermo fisher Scientific
Natalie C. TwineNatalie C. Twine
Instrument Sales Representative-Genetic Analysis at Thermo Fisher ScientificInstrument Sales Representative-Genetic Analysis at Thermo Fisher Scientific