PATEL SWEETY

**, ****** ******, **********,**,***03

Cell No.862-***-****

acn6uy@r.postjobfree.com

OBJECTIVE:

To obtain an Analytical chemist/ Pharmaceutical chemist/ Scientist position that will promote growth, stability and opportunity

for advancement.

SUMMARY:

Extensive knowledge of US and ICH safety reporting regulations and guidelines.

Basic knowledge of drug development process, clinical trial process and clinical development plans.

Knowledge of cGMP,USP, and FDA guidelines.

Experience in raw material and finished product analysis by wet chemistry.

Knowledge and understanding of all general SOPs pertaining to the analytical laboratory

Good understanding of IND safety reports, 21 CFR part 11,CGMP, GCP, GLP, ICH and HIPPA guidelines

Experience with common analytical techniques such as; HPLC, GC, NMR, UV, LC-MS.

Able to troubleshoot analytical methods and laboratory instrumentation.

Proficiency in computer applications like MS Office

Excellent communication skills, both written and verbal

Demonstrated ability to adapt quickly, prioritize tasks appropriately and work as a team

Possess good leadership, problem solving and time management skills.

EXPERIENCE:

Q-Tech Solutions. Inc., Somerset, NJ Feb2014-Aug2014

Drug safety associate Intern

Entered adverse events reports into the safety database .

Reviewed adverse events for completeness, accuracy and appropriateness for expedited reporting.

Performed Coding, narrative preparation, case processing, data entry and routing of all serious and

non-serious adverse events.

Ensured proper coding (MedDRA) into the global AE database.

Ensured all cases that require expediting reporting to worldwide regulatory agencies are processed

swiftly and appropriately within required timelines.

Entered data and relevant information from Extracted medical records into safety database screens in

a word format.

Requested follow-up using appropriate communication methods. (e.g., Fax, email, Telephone, or site

visit)

Assisted in the preparation of listings for Annual IND reports, Periodic Reports (PRs) and Periodic

Safety Update Reports (PSURs).

Performed AE-SAE reconciliation

Performed triage for seriousness, relatedness, and expectedness and prioritized of incoming adverse

events as per the protocol, investigator brochure.

Reviewed the given ICSR and SAE report form.

CVS Pharmacy, Montclair, NJ Feb 2013- To Present

Registered Pharmacy Technician (Part time)

Helping health care providers and patients by greeting them in person and by phone.

Answering questions and requests; referring inquiries to the pharmacist.

Maintaining records by recording and filing physicians' orders and prescriptions.

Ensure medication availability by delivering medications to patients.

Maintain Pharmacy inventory by checking pharmaceutical stock to determine inventory level.

Anticipating needed medications and supplies; placing and expediting orders; verifying receipt;

removing outdated drugs.

Processing insurance claims.

Epoch Pharmaceutical. Pvt.Ltd.,Vadodara, India May2011-Nov2011

Chemist

Performed sample preparation and solvent extraction.

Performed quality control testing for raw materials, product, and environmental samples, according to approved standard

operating procedures and cGMP, GLP, and FDA safety guidelines.

Managed and maintained daily manufacturing database.

Stability studies in support of formulation development using HPLC, GC, and other analytical techniques.

Reviewed and analyzed raw materials and finished products stability studies and non-routine samples.

Conducted LC/MS, HPLC, GC, UV, IR, KF, and wet chemistry testing in routine.

Prepared and organized regulatory submissions for internal partners (e.g., Drug safety or Graphics Dept.) constant data entry

including entering patients detail information into database for processing purposes.

Managed lab equipment and calibration/ qualification records on a regular basis.

EDUCATION:

NEW JERSEY INSTITUE OF TECHNOLOGY, Newark,NJ 2015 (Expected)

Master degree in pharmaceutical chemistry

R.C.PATEL COLLGE OF PHARMACY&RESEARCH CENTER,India,MH 2011

Bachelor’s degree in pharmacy (B. Pharma)

Educational Exposure: Clinical and Hospital pharmacy, Pharmaceutical Analysis, Advanced Organic chemistry, Pharmaceutics,

Dosage management from Design, Instrumental analysis lab, Analytical chemistry.

CERTIFICATION:

1 Drug safety associate ( Trials) Certificate: Pharmaceuticals-US Regulations

Q-tech solution, state of New Jersey, Department of education

2 Registered pharmacy technician

New Jersey office of the attorney General, Division of consumer Affairs

TECHNOLOGY SKILLS:

Microsoft Word, Excel, Outlook, PowerPoint

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