Carla Rosas Torres

Farmacéutica con más de 8 años de experiencia en Farmacovigilancia en la hospitales, en la industria farmacéutica y CRO.

Operation Specialist 2 , IQVIA May 2021 — Dec 2022 Mexico city • Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. • To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information • Determining initial/update status of incoming events  • Database entry • Coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. • Creating, maintaining and tracking cases as applicable to the project plan. • Perform activities related to adjudication as applicable Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting. Liaise with manager for regulatory tracking requirements and electronic reporting. • Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate. Ensure to meet quality, productivity and delivery standards per project requirements. • Ensure compliance to all project related processes and activities. Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed. Drug Safety Associate 2 (temporary contract), 

PRA Sep 2020 — Apr 2021 Mexico city • Tracking of received ICSR Entry of ICSR into company or client safety database Query management  Generates concise, accurate and well-written case narratives.   • Performs consistent coding of diseases, adverse events, and medications according to the projectspecific  coding conventions in the Safety Database.  • Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.  •  • Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with  relevant legislation and the project-specific contractual agreement, including electronic submission to the  EudraVigilance database (EV Web application or Gateway).   • If SAEs are reported from blinded trials, the DSA assures maintenance of blinded treatment code,  specifically when involved in the unblinding for regulatory reporting purposes. Generates data listings  from the safety database and assumes responsibility for accuracy of the data.  • Supports interim data analysis for DMC reviews. Receives inquiries via phone, fax or email from  consumers or healthcare professionals in support of marketed products; triages the inquiry as a request for  medical information, product quality compliant and/or adverse event and processes received information  in accordance with project specific instructions. Properly documents all internal and external contacts and  communications (e.g. with reporters of cases, sites, or clients whether verbal or written). 

Pharmacovigilance Officer / Sr. Pharmacovigilance Office , Bayer May 2015 — Mar 2020 Mexico City • Receiving (by fax, e-mail or phone call) and processes individual case safety reports (ICSR; e.g. serious adverse events, adverse events of special interest, and suspected ADRs) from clinical trial, spontaneous and from published reports (e.g. from the literature, received from Regulatory Authorities). • Submitting safety reports to Regulatory Authorities in Latin America and Spain • Responsible for coordination activities for Case Management Team • Follows-up on cases as appropriate • Tracking of received ICSR Entry of ICSR into company or client safety database Query management Generates concise, accurate and well-written case narratives.   • Performs consistent coding of diseases, adverse events, and medications according to the projectspecific coding conventions in the Safety Database.   • Assesses reportability of ICSRs based on the project-specific Safety Reporting Assessment sheet.   • Submits safety reports to Regulatory Authorities, IRB/ECs, and investigational sites in accordance with relevant legislation and the project-specific contractual agreement, including electronic submission to the EudraVigilance database (EV Web application or Gateway).   • If SAEs are reported from blinded trials, the DSA assures maintenance of blinded treatment code, specifically when involved in the unblinding for regulatory reporting purposes. Generates data listings from the safety database and assumes responsibility for accuracy of the data.   • Supports the generation of Aggregated Safety Reports (e.g. EU Annual Safety Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks.   • Supports interim data analysis for DMC reviews. Receives inquiries via phone, fax or email from consumers or healthcare professionals in support of marketed products; triages the inquiry as a request for medical information, product quality compliant and/or adverse event and processes received information in accordance with project specific instructions. Properly documents all internal and external contacts and communications (e.g. with reporters of cases, sites, or clients whether verbal or written).   • Follows-up on cases as appropriate Serves as Lead Drug Safety Associate and coordinates large or global teams of drug safety associates and safety data coordinators on project level, serves as the drug safety point of contact for study teams on project level. Functional analyst , 

Health Digital Systems Jan 2014 — May 2015 Mexico City • Business process analysis related to pharmacovigilance, drug management, and unit dose drug delivery systems in Mexico and Ecuador. • Processes modeling with the Bizagi tool. Clinical Pharmacist , Médica Sur May 2012 — Jan 2013 Mexico City • Reporting suspected side effects, adverse events, quality concerns and medication errors. • Submitting information to the Health Authority related to adverse events. • Performing pharmacotherapeutic follow-up in the pediatric population. • Training for health care professionals

UAEH- Licenciatura en Farmacia

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UVM-Marketing farmacéutico

ILEP-Diplomado en inteligencia emocional (2022- continúa)

Universidad Humanitas- Licenciatura en Psicología (2023-continúa)