Pharmacovigilance Specialist

Teresa Pascoe

***** *. **** **. ***** FL ***** Email: **********@*****.***

Tel 813-***-****

Pharmacovigilance Specialist

Translate and process spontaneous events and enter them into the database

for Adverse Drug Experience (ADE) reports. Conduct reconciliation of

adverse events reports received and submit to regulatory authorities.

Ensure organization meets drug safety and regulatory compliance guidelines

and support process improvements using industry best standards.

Drug Safety Pharmacovigilance (PV) Expert Operations Regulatory

FDA Reporting

SOP Compliance Oracle AERS MedDRA COSTART

Career History

Pharmacovigilance Specialist - Bausch + Lomb, Tampa FL Sep

2001 - May 2011

. Collected data and processed Adverse Drug Experience (ADE) reports

according to SOP

. Provided medical information to all spontaneous drug inquiries

. Reviewed ADE files for closure and FDA 3500A/E2B/CIOMS in

preparation for submission

. Created and prepared Annual Periodic Reports for FDA submission

. Directly interface among company, healthcare providers and patients

. Provided medical information to the public and monitored the

website for accuracy

. Developed a database dedicated to hosting Pharmacovigilance

literature articles

. Trained new staff on corporate standards, operations, procedures

and practices

. Received award for participation and expertise in Renu MoistureLoc

recall

. Appointed by the Director of Global Safety and Vigilance Operations

to participate on a global committee headed by the International

Alliance of Dietary Food Supplement Association to develop a Global

Guide to The Handling of Adverse Event Complaints, Guidelines for

Supplement Companies.

Office Manager - Rochester Nurses' Registry, Rochester NY

Feb 2000 - Sept 2001

. Provided office management and set up procedures for filing,

recording, document management and mail distribution

. New York State Licensed & Bonded to direct the placement activities

of all nurses to healthcare facilities

. Supervised placement activities to achieve and maximize cost

savings

. Managed financial records and responsible for accounts payable

Teresa Pascoe Resume Page 2

Patient Care & Administrator - Highland Hospital, Rochester NY

Dec 1989 - Dec 1999

. Supported RNs and Doctors in a fast-paced, multiple department

medical facility

. Coordinated departments and staff for patient tests, orders and

prescriptions

. Admitted, transferred and discharged patients via the computer

. Ordered necessary medical and clerical supplies for the various

departments as needed

. Assisted RNs for patient care including EKGs, phlebotomy, catheter

placement and more

. Conduct Basic Life Support classes as a certified BLS instructor

Education / Associations

Drug Information Association, Online eLearning Course

Medical Communications Certificate Program (June 2003)

Drug Information Association, Annual Conference, San Antonio TX

Pharmacokinetics: A Gentle Introduction, 2 Credit Hours

Rush Henrietta Adult Continuing Education, Henrietta NY

Beginning and Intermediate Excel (2000)

Highland Hospital Department of Education, Rochester NY

American Heart, Basic Life Support Instructor (1998)

Drug Information Association Member (Oct 2001 - Present)

Computer / Technology Skills

Oracle AERS, MedDRA, COSTART, Ovid, Lotus Notes, MS Office

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