Alina Trindade

Dedicated and dutiful pharmacovigilance professional with 5+ years of experience in the pharmaceutical industry and regulatory authority. Oversighted effectively the safety of sponsored clinical trials, provided regulatory intelligence and processed clinical and post marketing sources. Conducted extensive and productive communications with internal and external partners, leading to successful working relationships.  Keen to apply an analytical and proactive approach to drug safety issues and enhance communication between stakeholders and regulators.

Arriello, Lisbon                                                                                               September 2023 – April 2024

Leading provider of pharmacovigilance, regulatory and quality & compliance consultancy, and operational services.

Global Drug Safety Manager

• Managed a group of PV specialists, PV associates and PV assistants within the assigned projects.
• Executed of pharmacovigilance technical tasks such as Global Individual Case Safety Reports (ICSR) processing in safety database (Veeva Safety Vault), preparation and revision of safety management plans on behalf of clients, set-up of study in the safety database, SAE reconciliation, 3 months line listings.
• Collaborated with finance department to produce sales order that support the invoices of given projects.

Jazz Pharmaceuticals, Cambridge

Global biopharmaceutical company with expertise in neuroscience (sleep disorders and epilepsy) and oncology (haematological malignancies and solid tumours).

Senior Clinical Safety Specialist                                                                December 2021 - December 2022

Safety lead for Legacy GW sponsored studies

• Participated in study calls including medical monitoring meetings, providing safety inputs regarding medical queries that affected patients’ safety. 
• Set-up of several studies in the global safety database (Argus) to collect data that was relevant for submission to the regulatory authorities.
• Performed activities such as Serious Adverse Events (SAEs) reconciliation and MedDRA and concomitant medication coding, aggregating clean data that was submitted for marketing authorisation applications in Europe and United States.
• Reviewed protocols, informed consent forms and created/managed pharmacovigilance (PV) plans to ensure patients’ safety. 
• Provided support on routine safety surveillance of clinical studies for products with an active clinical development program by retrieving requested data from Argus in a timely manner.
• Reviewed DSURs, PBRERs, PADER, safety evaluation reports and risk management plans for quality control.

GW Pharmaceuticals, Cambridge                                                            January 2018 – December 2021

Global biopharmaceutical company with expertise in plant-derived cannabinoid products to treat multiple sclerosis and rare forms of epilepsy (neuroscience therapy).

Senior Associate Pharmacovigilance                                                     October 2019 – December 2021

Case processor, safety lead for GW sponsored studies and PV contact for external business partner

• Provided regulatory intelligence for Europe and Rest of the World to support the team with individual case safety reports (ICSRs) submissions to the regulators.
• Prepared and delivered case processing guidelines to enhance the PV processes and ICSRs quality.
• Reconciled SAEs, performed MedDRA and concomitant medication coding to assist the team with the creation and quality of safety reports in Clinical Study Reports (CSRs).
• Responded to safety related queries from internal and external partners to ensure compliance with the regulations.
• Conducted case processing, including data entry, review and assessment of SAE/AE reports, narrative writing from clinical trial and post-marketing sources into Argus which increased the compliance submission above 90%. 
• Supported the team with a successful data migration from GW Argus to Jazz Argus databases, as per defined timelines. 
• Performed literature review to retrieve potential ICSRs and promptly raising any concerns about potential risks.

Pharmacovigilance Associate                                                                 January 2018 – October 2019

Case processor and PV contact for external business partner

• Processed clinical trial and post-marketing sources into the ARISg and Argus databases in a timely manner.
• Supported the team with a successful data migration from ARISg to Argus, as per defined timelines. 
• Performed literature review to retrieve potential ICSRs.
• Reconciled SAEs, performed MedDRA and concomitant medication coding to assist the team with the creation and quality of safety reports in CSRs.
• Answered to safety related queries from internal and external partners to ensure compliance with the regulations.

Pharmacovigilance Trainee                                                                       March 2016 – September 2016

INFARMED, National Authority of Medicines and Health Products, IP, Lisbon, Portugal

• Triaged and performed case processing of spontaneous reports of suspected adverse reactions from healthcare professionals, patients and marketing authorisation holders, ensuring the key performer indicators were achieved.
• Validated educational materials and direct healthcare professional communications, delivering high quality analysis.

Pharmacovigilance Trainee                                                                       March 2015 – March 2016

Southern Pharmacovigilance Centre, Lisbon, Portugal

• Triaged and performed case processing of spontaneous reports of suspected adverse reactions from healthcare professionals and patients who live in the southern Portugal, decreasing the teams’ workload.
• Collaborated in causality assessment, safety and quality reports for signal generation by proactively gathering data.

Master degree in Pharmaceutical Sciences - Faculty of Pharmacy of the University of Lisbon, Portugal