Safety Management

HARDIK PRAJAPATI

** ******* *** *** # *, Jersey City NJ 07306

****************@*****.*** Ph No.201-***-****

EXECUTIVE SUMMARY

1+ years of experience working as a safety drug associates in Pharma Links

6 months internship of safety drugs associates in Cadilla Pharmaceuticals Inc. in India.

SKILLS

Broad knowledge of national and international drug safety regulations, industry practices and

standards.

Knowledge of MedDRA and WHO DRUG coding dictionary.

Case report form (CRF) review and protocol implementations

Good analytical and planning ability with commitment to achievement of safety objectives and targets.

An effective communicator at all levels within the organization.

Performed and ability to do blood component analysis, animal anesthesia

Study the pharmacology of the drug (agonist, antagonist) in various tissues (ileum, fundus, uterus of

rat, mice and guinea pig)

Bioassay of drugs like anesthetics, hypnotics, epileptics, depressant, antihistaminic via appropriate

instruments like elevated plus maze method, Rota rod test, electric shock induced pain; various media

preparation and to check the bio-availability of the drugs using various dosage forms

Other Skills:

Proficient in MS Office: MS Word, MS-Excel, MS-Outlook and MS-Access, ARGUS Database, QA

tools.

Excellent Technical writing skills, oral communication and negotiation skills.

Strong interpersonal, Presentation, Financial, Budgeting and Leadership skills.

Maintain documentation, record keeping and collection of clinical research data.

Working knowledge of GCP, ICH, FDA, GMP and GLP regulations.

Prepared and revised scope for SOPs and forms.

WORK EXPERIENCE

One year of experience working in Pharma Lynx as a Safety Drug Associates

(May 2010-April 2011)

Process adverse drug and device experiences concerning marketed products or serious adverse event

reports for investigational products.

Strong Knowledge of Clinical Trials, Phase I, II, III, IV and post surveillance reports.

Review serious adverse event reports to identify missing, inconsistent or erroneous data and check for

duplicate cases.

Enter safety data into the client safety database with the ability to interpret the received report

sufficiently to complete all necessary fields.

Evaluate and process serious and non-serious ADR’s from all different sources including clinical trial

using ARGUS databases, which includes use of WHO Drug Dictionary, appropriate MedDRA coding

of AE terms

Interpret and apply current department SOPs, FDA, ICH and EMEA guidelines and regulations as they

pertain to Drug Safety.

Preparation of U.S. Periodic Reports and International Periodic Safety Update Reports

Participated in product meetings within the drug safety department.

Safety narratives and prepares adverse event reports for medical review and submission to regulatory

authorities, mainly focusing on clinical SAEs.

Internship of 6 months in Cadilla pharmaceuticals, which is one of the innovating

pharmaceutical companies of India (May 2007- Aug 2007)

(May 2008- July 2008)

Collected, documents, and processed adverse event (AE) reports from clinical trials and post-

marketing sources adhering to Standard Operating Procedures.

Prepared clinical narrative summaries for ‘Adverse Event’

Performed active follow-up via telephone contact with consumers and health care

professionals.

Participated in preparing safety reports and maintained clinical databases. Gained insight into

product desirability and large-scale formulation production

Perform safety review and process adverse event & product complaint reports based on

corporate and global regulations and guidelines for submission to Regulators World-Wide.

Participated in reconciliation of reports for PSUR and periodic reports and communicated the

findings to the colleagues

Write letters to health care professionals, consumers and Clinical Research physicians/staff to

obtain further information

Worked as a Volunteer Intern for 3 years in Gujarat Blood Bank and laboratory in India

(May 2004- May 2007)

Collection & processing of blood samples.

Successfully performed Laboratory test on blood samples like for RBC and WBC count, Serology

tests

(ELISA Test), blood glucose level, checking blood group, checking hemoglobin level, etc

Checking heartbeats, blood pressure, etc.

ACHIEVEMENTS

Participate in the national Level Symposium “INNOVATION” For a paper presentation with Title

“STEM CELL TEHRAPY”

Presented Technical Poster on Diagnosis of Heart Disease by Stem Cell Therapy in 2006

Participated in Annual convention of ISTE students, Gujarat state and Presented Poster presentation

on Tablets in 2005

Presented Technical Poster on Herbal Drugs verses Allopathic Drugs in 2004.

Participated in training of Public Speaking in AMA.

EDUCATION

Masters of Science in Technology Management, University of Bridgeport, Connecticut

(Biotechnology, Healthcare Management, Marketing, Business Process Management.)

GPA: 3.7/4.0

Bachelor in Pharmacy in C. U. Shah College of Pharmacy and Research, India

(Bio Pharmaceutics & Clinical Pharmacokinetics, Clinical Pharmacy, Biochemistry, Biotechnology &

Biological Pharma, Pharmaceutical Technology, Pharmaceutical Microbiology, Medicinal Chemistry,

Pharmaceutical Engineering, Pharmaceutical Analysis, Organic Chemistry, Anatomy Physiology & Health

Education, Pharmacology.)

GPA: 3.3/4.0

REFERENCES

Name: -Dr. Ashok Srivastava (CMO, DM, PhD., MD, MBA)(Pharma Lynx)

Email id: - ******@*****.***

Phone No: - 908-***-****

More reference will be available upon request

Contact this candidate