SUMMARY: Analytical and results-driven professional with recent transition into drug safety. Ability to drive organizational change at the operational level, cultivating strategic partnerships, and engaging with cross-functional stakeholders to uncover and address pharmaceutical safety issues.

EDUCATION:

Fitchburg State University: MBA Healthcare Management (August 2023)

University of Phoenix: Bachelor of Science in Business Administration

Udemy – Pharmacovigilance Training Certificate course (2023) Course-2023

SKILLS:

Veeva docs, Veeva eTMF, Veeva Magellan, eReliance, Box, Argus, Tableau, Monday.com, Process Flow Diagrams & Visio, Excel VlooKups, Pivot Table,

Recognition: Mentioned on Nucleus as a Q1 2023 Sarepta Learning Champion.

Nomination: Represented Sarepta at Boston While Black Summit– April 2023.

Attended FDA Regulatory Education or Industry (REdI) Annual Conference 2023 (June 5th-9th).

Employee Resource Group Membership: Sarepta Women’s Alliance, HUES, and Spark.

PROFESSIONAL EXPERIENCE:

Sarepta Therapeutics Remote Jan. 2022- Aug. 2023

Global Pharmacovigilance Quality Management Associate

Global Biopharmaceutical company focused on novel treatments for Duchenne Muscular Dystrophy, Limb-Girdle Muscular Dystrophy, and Charcot -Marie-Tooth Disease. Gene Therapy, RNA exon skipping, and Gene Editing are used to develop genetic medicine.

Managed drug safety inbox

Processed Adverse Events (AEs)/Endpoints according to Standard Operating Procedures (SOPs), and project specific safety plans.

Reviewed literature articles and abstracts to identify valid ICSRs

Performed data entry of post-marketing and clinical ICSRs into the safety database

Completed Adverse Event reconciliation for ICSRs received from partners

Assisted in the preparation of periodic safety reports, and other documents, as needed

Assisted training New Hires and Vendors on AEs; creation of training slide deck, materials for process and procedure updates and rollouts.

Audit and Inspection Monitoring: Participated in 2022 Sarepta Arm Pharmacovigilance Audit (Pre- audit active, Audit and Audit Responses/Close out).

Assisted in SIR Review & Quality Event execution for CAPA Management

Compliance Monitoring: Assisted in creating weekly compliance reports KPIs & Metrics; extracting data for training schedules from Veeva and CAPA & Quality Events data from reliance to create a comprehensive training report.

Knowledge to of Medical Terminology GVP regulations, (FDA/EMEA), GCP, ICH, MedDRA.

Logix Inc Waltham, MA Oct. 2016 - Jan. 2022

Director, R&D Life Science Division Jan. 2020 - Jan. 2022

Life Science Recruiter Oct. 2016 - Dec. 2019

Life science recruitment firm. Clients: (Pharmaceutical, Biotechnology, CROs, and Medical Device companies). Clientele: (Stealth mode, startups, mid-size, and global companies). Positions: (All levels: Associates, Managers, Associate Director, Directors, VP). Phases: Drug discovery phase, Preclinical phase, Clinical Development, Phase IV, Commercial and Post Marketing.

Therapeutic areas: Oncology/Hematology, Gene Therapy /Cell therapy, CNS, Hematology, Neurology, Infectious/ Vaccine, Rare /Orphan, Biologics, Immune-oncology, Autoimmunology/ Inflammation, Ophthalmology, pediatrics, Respiratory and diagnostic.

Partnered with hiring managers to discuss job requirements and assess applicants’ qualifications.

Trusted talent adviser to hiring managers/ human resources of talent insight and market demand.

Point of contact for human resources/ hiring manager on various recruitment needs in a strategic and consultative manner.

Leveraged various methodologies to identify candidates: sourced, screened, and developed a steady talent pool from passive candidates.

Managed candidates’ application and interview process to ensure a positive candidate experience with clients.

Extended offers /negotiated offers on behalf of candidates and communicated verbal acceptance to clients.

Additional Experience:

Monster.com recruiter Weston, MA Dec. 2015- Oct. 2016

CROMSOURCE, Inc. (CRO) Recruitment Associate/ Cambridge, MA. Feb. 2014 -Apr. 2015

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