May Contreras

• Support and collaborate with business partners to develop ASR/RMPs prepared by partners to ensure submission compliance within BeiGene’s territories. - Coordinate regional appendices preparation with applicable contributors and provide regulatory guidance.
• Support and coordinate the local translation process as needed.
• Review ASR/RMP-related documents, including but not limited to the Pharmacovigilance Agreement (PVA), Pharmacovigilance Safety Master File (PSMF), Safety Management Plan (SMP), Safety Reporting Plan (SRP).
• Leading critical process or sub-process areas as well as project initiatives within GPS organization or as GPS representative to other functions
• Assist in the development of department-specific SOPs and Work Instructions.
• Support internal and external GPS department trial audits or inspections.
• Assist the line manager to participate in other department projects as needed.
• Act as the backup of ASR Lead
• Receives information on each Interstitial Lung Disease (ILD)/Pneumonitis Adjudication Committee (IAC) event and builds the dossier for submission to the IAC members as directed by the charter;
• Follows up with Investigator Sites and Clinical Teams (as applicable) for documents to complete the dossier as needed;
• Assists the Chair in the preparation of the IAC Charter, meeting agendas, and meeting minutes;
• In conjunction with BeiGene and the Chair, schedules the IAC Organizational Meeting and review meeting;
• Assists BeiGene in the coordination of the IAC meeting logistics;
• Collates and distributes meeting materials to the IAC as appropriate;
• Tracks classifications and disagreements between the IAC;
• Facilitates the collection of additional source documents requested from the IAC; and,
• Sets-up and maintains IAC Master Files.

• Reviewing and tracking literature search results and ICSR coming from vendors.
• Perform monthly ICSR submission report from vendor.
• Reviewing of final SUSAR submission report.
• Vendor oversight (safety point of contact between Reacx and Vendor).

• Elevation Oncology

Drug Safety Associate- Mar 2020 to Present

· Performed data entry of legacy cases to the Argus Safety Database.

· Performed case entry to the Argus Safety database from intake, triage, MedDRA coding and authoring narrative for the single patient study.

· Perform review of ICSR cases from CRO.

· Overseeing CRO and ICSR point of contact.

· Therapeutic area focuses Oncology (Gastric cancer)

• Tocagen

Safety Operations Manager- Mar 2019 to Oct 2019

· Safety point of contact between Tocagen and Vendor.

· Reviewed ICSR cases in the Argus safety database for all studies SUSAR and non-SUSAR cases from Tocagen’s vendor.

· Developed and reviewed SOPs and Guidelines and Work Instructions.

· Worked with Data Management with SAE reconciliation.

• Loxo Oncology

Drug Safety Associate - Jan 2014 - Mar 2019

· Supported Loxo Oncology from start to drug approval.

· Developed and reviewed adverse event processing SOPs, Guidelines and Work Instructions.

· Managed clinical study ICSR including intake, triage, MedDRA coding, authoring narratives, quality checking, querying of health care providers/other reporters and ensuring submissions.

· Performed SAE reconciliation from Clinical Database and Safety Database.

· Participated in the implementation of the Argus Database.

• Performed monthly reconciliation of SUSAR submissions and partner individual case safety report (ICSR) transmission.
• Ensured all regulatory submissions are done properly.
• Oversaw drug safety and PV mailbox.
• Performed literature search and review results output.
• Performed quality review of Clinical Study Report (CSR) narratives for closed studies.
• Reviewed SOPs and providing expertise in PV documents review.
• Reviewed of monthly SAE reconciliation between the clinical safety database and the safety database from vendor.
• Sent and tracked queries to Investigators for the Investigator initiated study.
• Kept track of updates to the ECR Investigator contact lists and sending the weekly list to the vendor.

· Performed quality review (QR) of individual case safety report (ICSR) from Mersana’s vendor.

· Managed workflow and tracking ICSR.

· Performed monthly Serious Adverse Event reconciliation (SAE) from the Clinical database and Safety database.

· Reviewed of outstanding queries sent to site.

· Managed clinical study ICSR MedDRA coding, authoring narratives, quality checking, and querying of health care providers/other reporters.

· Supported several clinical and post-marketing safety activities, including but not limited to, the handling of cases received from partners, ensuring the uniform and timely intake, processing, and submission of individual case safety reports.

· Reporting safety information to regulatory agencies in compliance with global regulations and Halozyme standard operating procedures.

Reviewed clinical trial and post-marketing safety information.

• Managed clinical study individual case safety report (ICSR) including intake, triage, MedDRA coding, authoring narratives, quality checking, querying of health care providers/other reporters and ensuring submissions.
• Tracked expedited reports for regulatory submissions.
• Supported safety database activities and initiatives (Oracle AERS, Argus/LSS, InForm, training, technical issue resolution).
• Developed and reviewed adverse event processing SOPs, Guidelines and Work Instructions.
• Maintained and completed corporate and departmental training requirements.

• Individual Case Safety Report (ICSR) case processing including MedDRA coding and creating narrative summaries for post-marketing spontaneous SUSAR and non-SUSAR cases.
• Processed between 10-12 cases daily for Amgen in therapeutic areas that included rheumatology, oncology, women's health, and nephrology.
• Supervised case entry of safety team members monitored productivity metrics and ensured timelines are met. Directed QC review to ensure high quality entry and customer satisfaction.
• Fulfilled leadership role for Safety.
• Conducted safety database and case entry training for all new associates.