Safety Surveillance Associate Resume
NJ
CAREER SUMMARY
- Specialized in Pharmacy Management and serving as an effective liaison between the healthcare team and the community to improve drug usage and therapeutic outcomes.
- Thorough knowledge of computerized drug-distribution systems, drug-utilization evaluation, complex equipment and delivery systems
- Knowledge of Drug Safety Surveillance, advancing and promoting the field of global patient safety.
Doctor of Pharmacy (Pharm.D) Aug 2006- Nov 2008.
Nova Southeastern University, College of Pharmacy, Fort Lauderdale, FL
Bachelor of Science in Pharmacy (Pharmacy BS) 2001-2005
K.B Institute of Pharmacy,
Gujarat University, Gujarat, INDIA
New Jersey Board of Pharmacy, registered pharmacist. (2009- Present)
American Heart Association, Basic Life Support with AED certification WORK EXPERIENCE
Relocated to New Jersey in June 2009
Confidential,
Jul-2009- current
Bridgewater, NJ
Safety surveillance associate
Responsibilities-
- Provide support for the review of potential adverse events of Pfizer products.
- To review and assess domestic/international clinical trial and post-marketing surveillance AE reports on marketed products.
- To determine regulatory reporting requirements based on assessments of seriousness and labeling of selected AE terms.
- Identify and select routine cases for processing, determining appropriate prioritization criteria, and noting reasons for any delays.
- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately.
- Requesting follow-up (written or telephone), assessment of follow-up reports.Review case criteria to determine the appropriate workflow for case processing. Write and edit the case narrative.
- Generate reports, ensuring adherence to regulatory compliance timelines.
- Determine and perform appropriate case follow-up, generating and requesting follow-up letters.
- Liaise with key partners, including Pfizer Country Organizations, Clinical Development, License Partners, and other stakeholders regarding safety data collection and data reconciliation.
- Work on SLP (Streamline Process) - Accept cases though Drop in Data Entry (DIDE II) system, complete post save procedures,perform classify-1 triage–(seriousness assessment) and classify-2 triage (company causality assessment) and forward the cases to appropriate therapeutic team
- Consistently apply regulatory requirements and Pfizer policies. Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities.
Confidential,
Pharmacy Intern
Manager- David Derby. Rph
Responsibilities-
- Enter, Scan, Type and fill prescriptions.
- Assist patients in selecting appropriate OTC medications.
- Contact Physician for prescription clarification.
- Verify possible drug interactions/drug information and adverse events
- Contact other pharmacies for transferring prescriptions.
- Provide clinical data to providers.
- Assist patients in insurance related problems.
- Utilize parata-filling system, assist with audits and perform expired and overstock returns.
- Make an order for out of stock medication through Cardinal and Warehouse.
- Prepare and dispense prescription medications.
- Receive and process verbal prescription orders from prescribers. Assess and recommend nonprescription medications. Counsel patients on prescription medications and delivery devices.
Confidential,
India Oct 2005- Oct 2006
Pharma Intern
Supervisor- Himanshu Patel, director Gelikaps pvt. Ltd
Responsibilities-
Quality Control
- Raw material analysis
- Packaging material analysis
- Perform Weight variation and limit tests for raw material and packing material
Production Department
- Examine Preparation of gelatin mass.
- Medicament preparation and monitoring functioning of Encapsulation machine
- Preparation of Process Validation Protocol, Batch Master Record.
Quality assurance department
- Draft and revise standard operating procedures and various GMP documents. Assist in preparing and issuing Batch Production Records for Manufacturing and Packaging.
- Conduct internal GMP compliance audits and assist in hosting GMP audits by external parties.
- Assist in maintaining files and assist in the review and destruction of outdated records.
Audit incoming material inspection / testing records and release of incoming material.
DOCTOR OF PHARMACY CLERKSHIPS
Confidential,
10/08-11/08
Preceptor-Mathew Seamon, PharmD, JD
Responsibilities-
- Utilization of techniques to provide evidenced-base recommendations to formal drug information requests and systemic approaches to evaluate drug information.
- To locate sources of primary literature by using thorough databases.
- Prepare formal presentations on tertiary literature sources.
- To participate in journal club discussions and to prepare drug information e-newsletter.
Presentation: “Aspartame Safety Concerns” during the drug information Forum and Evidence-based In-service.
Confidential,
09/08-10/08
Preceptor- Michael Kaplan, PharmD
Responsibilities-
- To type and fill the prescriptions according to the filling Preference e.g. bottles, blisters, medication on time packages and Peck Med packages.
- To visit different assisted living facilities assigned with Medic Pharmacy to update the MARs and to check medication carts for expired drugs, Cleanliness and temperature maintenance.
- MARs needed to be checked for daily signatures of the assigned nurse for each dose administered, Stop orders/new order, right dosage calculation, PRN medication records.
- To guide nurses on diet needed to be maintained for patients on certain medications such as Coumadin, Blood pressure medications etc. by giving in-service and formal presentations
- To take doctors calls for the new prescriptions and to call doctors for the refill approvals and prescription verification.
- To visit Hospice units to check the patient’s charts for drug interactions, report adverse events, therapeutic duplication,
Presentations: 1.In-service presentation on Alzheimer’s disease, for pharmacists
2. Presentation on “guidelines on Medicare Part-D Fraud, Abuse and Waste.”
Confidential,
08/08-09/09
Hollywood, Ft.Lauderdale -FL
Preceptor- Zachary Eisenmen, PharmD
Responsibilities-
- To compound different drug formulations like ointments,
Cream, emulsions, and suppositories and certain hormonal preparations
- To fill capsules of different sizes using encapsulation machine.
- To compound syrups and suspensions used for veterinary purposes.
Coral springs Medical Center 07/08-08/08
Coral Springs, Ft.Lauderdale -FL
Preceptor- Andrea Seitzman-seigel, PharmD
Responsibilities-
- Adjust the doses of Vancomycin and Gentamycin according to their Pharmacokinetics, Daily monitoring of Peak/trough concentrations for dosage adjustment and toxicity analysis.
- Check appropriate doses of Coumadin and Lovenox for patients with poor renal clearance.
- Study patient’s charts for appropriate DVT/PE prophylaxis.
- Help Pharmacist for daily TPN calculation
Confidential,
06/08-07/08Miramar, Ft Lauderdale-FL
Preceptor-Denise Roach Rodney, PharmD, MBA
Responsibilities-
- Join Daily patient’s rounding and suggest physicians appropriate drug choice according to CMS and Hospital Policy.
- Study each patient profile for allergies, renal dose adjustment, IV to PO conversion or any other appropriate changes before joining the daily rounds.
- Suggest appropriate DVT/PE prophylaxis for the patients who are at the risk of developing DVT/PE.
- Appropriate dosage adjustment of the Coumadin in A. Fib and other disease according to the new CHEST guidelines -2008
- Counsel Patients on Coumadin (diet and interactions) by visiting each patient personally. Counsel pharmacists on Vit. K administration (what dose, what route) in cases of bleeding.
Confidential,
05/08-06/08Oakland Park blvd, Lauderhill, FL
Preceptor-Dr.Howard Cheiken
Responsibilities-
- Study daily Lab reports of drug toxicity and report Adverse Events.
- Study patient cases based on intentional over dosage of Tylenol or other medications and administration of appropriate antidotes (e.g. dosage of Acetylcystine in case of Tylenol toxicity)
- Counsel patients on Coumadin. (Diet, drug interactions)
- Adjust the dosage of medications Lovenox, zyvox, vancomycin, Gentamycin according to renal clearance. Check daily drugs levels of Digoxin.
Confidential,
04/08-05/08
Oakland Park, Ft.Lauderdale, FL
Preceptor-Ekmal Farag, PharmD
Responsibilities-
- Assist pharmacist in daily INR check up and dosage adjustment in Coumadin Clinic. To arrange special classes for the patients to guide them on self-glucose monitoring, tips on diabetic diet and diet needed in various heart diseases, self-blood pressure monitoring, smoking cessation, etc.
- Daily blood pressure monitoring and blood glucose monitoring for assigned patients, to participate in pain management clinic.
- Counsel patients on medication compliance.
Confidential,
03/08-04/08
Miami, FL
Preceptor-Blanka Rivera, PharmD
Responsibilities-
- Join Daily Wound Care rounds and Psych. rounds with assigned physicians
- Adjustment of the dosage for renally eliminated drugs.
- Change IV drugs to PO if applicable, check blood count for the patients on Neupogen and Epogen.
- Assist pharmacist for In-service presentation on Comparing Daptomycin with Vancomycin in P&T committee meeting.
- Prepare Albumin order Form for Physicians for prescribing Albumin only for appropriate usage according to Hospital’s policy due to critical national supply shortage.
Confidential,
02/08-03/08Hollywood, FL
Preceptor-Margarita Kearson, PharmD
Responsibilities-
- Stock Pyxis station, join daily physician rounds and participate in patient’s therapeutic treatment plan discussion.
- To assist ER pharmacist in checking all pyxis and med carts for expiration and proper maintenance.
- Prepare presentation on Target doses of medicines used in CHF.
- To present new updates from CMS on hospital policies to all staff pharmacists.
- Study patient profile to assigned floor and to present it among all staff pharmacists.
Confidential,
01/08-02/08
Miami, FL
Preceptor: Robert Littman
Responsibilities-
- Check Carts for expiration date, proper storage temperature; verify the counting of control medications.
- Check all patients MARs and identify any drug changes, dosage administration time, discontinued medications, drug interactions etc.
- Check if Nurses have signed MARs properly and assigned nurses have given medications at proper time.
- Study patient’s chart and Present the patient’s case.
- Assist patients in choosing natural remedies like herbs and vitamins related products and discuss the advantages of natural remedies.
Confidential,
07/07-08/07
Plantation, FL
Preceptor-Robin Weinstocks
Responsibilities-
Filling prescriptions, checking for drug interactions, to call doctors for the prescription verification and to receive new prescriptions, to call other pharmacies for transferring prescriptions, Give proper guidance to patients about choosing OTC medication.
Confidential,
08/06-05/07Davie, FL
Preceptor: Rolando Torres, PharmD
Responsibilities –
Filling prescriptions assist in providing medication counseling. Assist MTM pharmacists to provide initial interview, data collection and input regarding patient’s therapeutic treatment plan, Participate in posters and journal club presentation discussions. To participate in special month-to-month programs assigned in clinic e.g. guiding patients on Flu shots, Glucose monitoring, Peak flow meter utilization for asthma.
PRESENTATIONS
1. Impact of Pharmacists on Asthma Education March- 2007
Nova Southeastern University, Poster night
Poster presentation on how Pharmacists can help children and adult educate about medication compliance and proper techniques to use inhalers. 2. Journal Club Presentation Feb- 2008
Memorial Hospital, Hollywood.
Effects of Clopidrogel and Aspirin in combination vs. Aspirin alone on activation and major receptor expression in diabetic patients.
3. Chantix- Information for pharmacists April- 2008
VA Oakland park outpatient clinic
Presented new CHEST Guidelines for the Coumadin initiation and proper dosage of vitamin K in case of Coumadin toxicity.
5. To train a staff Medicare part D Fraud, waste and abuse compliance policies
and procedures. Oct.-2008
6. To give an in service to the staff pharmacists on Alzheimer’s disease. Oct-2008
7. “Aspartame Safety Concerns” during the drug information Forum and Evidence-based In-service. Nov-2008
NSU community Fest February 2007
Nova Southeastern University, College of Pharmacy, Ft.Lauderdale, FL
-Participated and assisted at the pre-pharmacy Society booth.
NSU International Food Festival September 2007
Nova Southeastern University, College Of Pharmacy, Ft.Lauderdale, FL
Participated in Food Festival and assisted in food preparation and other arrangements and raised fund for RED CROSS.