MONICA ROIZEN

Woodcliff Lake, New Jersey ***** 917-***-**** adq782@r.postjobfree.com

PROFESSIONAL SUMMARY

Enthusiastic and eager to contribute to team success through hard work, attention to detail, and excellent organizational skills. Motivated to learn, grow, and excel in Global Pharmacovigilance. WORK HISTORY

Manager, Clinical Safety Scientist, 02/2021 to Current Daiichi-Sankyo – Basking Ridge, NJ

• Risk Management (Signal identification, evaluation, mitigation): develop and implement the risk management strategy for assigned oncology products. Assist CS physicians in assessing new signals. Analyze safety data from multiple sources to deliver comprehensive conclusions.

• Assist with developing strategy for communicating safety information internally and externally with CS physicians.

• Assist CS Physicians to interface with project team members including: Clinical Operations, Data management, Statistics, Regulatory and Project Management.

• Document meeting discussions, decisions, action items, and SMT activities. Ensure appropriate archiving of the team meeting documentation and SMT activities.

• Project Management for SMTs devoted to larger Phase 3/4 products and ensure adherence to project timeline. Identify gaps in safety surveillance plans/RMPs and escalate appropriately.

• Review clinical data within eCRF system, patient profiles, etc. to issue queries from a clinical perspective.

• Assist with preparation of key documents e.g., Investigator Brochures, regulatory submission documents.

Retail Pharmacist, 07/2017 to 12/2019

Plains Pharmacy – Wayne, NJ

• Verified accuracy and completeness of information on prescription and refill requests and filled orders.

• Advised patients on proper disease state management.

• Provided consultations and recommendations for OTCs, vitamins, and herbal products.

• Maintained patient confidentiality in all actions.

• Counseled patients on medication use and possible interactions and side effects.

• Ordered medications from distributors and properly preserved stock to ensure potency and safety.

• Communicated regularly with doctors’ offices via telephone, fax and email.

• Dispensed and handled record-keeping of controlled substances.

• Demonstrated use of home diagnostic and self-monitoring devices.

• Processed and resolved third party rejected claims.

• Maintained pharmacy records.

Drug Safety Associate, 09/2003 to 12/2005

Pfizer – New York, NY

• Responsible for the preparation and review of NDA Periodic Reports to be included for submission to domestic and international regulatory authorities (NDAs, PSURs, IND Annual Reports).

• Collaborated with internal (Safety Surveillance and Reporting Therapeutic Team, QA, other groups within RRG) and external (Clinical Teams) groups to ensure that tables are submitted in compliance with regulatory requirements.

• Monitoring of project timelines to ensure that tables are submitted within required timeframes.

• Ensured clear communication of project requirements contributing groups within and outside of SSR; promoted consistency and standards.

• Established relationships, interacted and communicated effectively with internal contacts, such as other groups within Safety Surveillance and Reporting, Worldwide Regulatory Affairs and other organizations within Worldwide Development.

• Actively participated in “Virtual Teams” aimed at ensuring optimum collaboration between the appropriate Therapeutic Team and the Reports group. Maintain current knowledge of Pfizer products and applicable regulatory/safety regulations and guidelines.

• Understand and maintain knowledge of SSR SOPs and practices.

• Verified proper coding using MedDRA and WHODRUG dictionaries.

• Interacted with members of appropriate interdepartmental and interdivisional teams to coordinate and ensure the integrity of safety data being provided in regulatory reports.

• Supported departmental initiatives and integration activities as required and conducted quality control review of safety data included in regulatory submissions. Clinical Pharmacist, 02/2003 to 09/2003

15W Pharmacy – Long Term Care Facility – Edison, NJ

• Created an in-house formulary for 17 nursing facilities.

• Met with physicians and nurses to discuss recommendations based on cost effective therapeutic equivalencies.

• Ordered medications from distributors.

• Maintained pharmacy records.

• Evaluated appropriateness of drug therapy.

• Dispensed medication orders.

Hospital Pharmacist, 12/2002 to 09/2003

Muhlenberg Regional Medical Center – Plainfield, NJ

• Monitored and evaluated appropriateness of drug therapy via medical chart review.

• Completed DUR forms with prescriber recommendations based on lab values, sensitivity results, renal/ hepatic function and patient's clinical state.

• Screened, prepared, evaluated and dispensed medication orders.

• Tracked medication errors by review of medication administration records, patient charts, pharmacy prescription profiles, and inspection of medication carts.

• Reported discrepancies as part of a quality assurance team.

• Provided drug information to healthcare personnel regarding drug therapy, proper dosing, administration, stability, chemical compatibility, storage, aseptic technique, and formulary changes. Pharmacy Intern, 07/1997 to 12/2002

Walgreens Pharmacy – Brooklyn, New York

• Screened, evaluated, and filled prescriptions, performed drug utilization review as per OBRA ’90, counseled patients on proper medication use, recommended over-the-counter products and nutritional supplements, demonstrated use of home diagnostic and self-monitoring devices, advised patients on proper disease state management, processed and resolved third party rejected claims, ordered medications from distributors, and maintained pharmacy records.

EDUCATION

Doctor of Pharmacy: Pharmacy, 05/2002

Long Island University - Brooklyn, NY

CERTIFICATIONS AND LICENSES

UMC Global Pharmacovigilance, Signal Detection, and Causality Assessment New Jersey Licensed Pharmacist

PUBLICATIONS

Roizen M. Physicians Expectations of Pharmacists. Newsletter of New York Methodist Hospital. January 2002.

Roizen M, et al. Are sulfonamides, sulfones, sulfites, and sulfates contraindicated in patients with a reported

(sulfa) allergy? Drug Topics. 2002; Aug 5; 37. May 2002.

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