drug safety associate

OBJECTIVE: To obtain a position that will enable me use my technological skills, educational background and establish a long lasting career in the field of Pharmacovigilence

SUMMARY SKILLS:

Federation of State Medical Board (FSMB) certified Medical Doctor (MD) with over 3 years of combined experience in drug safety and clinical practice

Basic acquaintance of FDA and ICH guidelines in regard to Drug safety

Extensive experience in post marketing surveillance

Global drug safety database knowledge with knowledge of regulatory roles

Effectively maintain the safety data base and corresponding entry guidelines with assurance of quality of data

Efficient in identifying and tracking the serious adverse events and non serious adverse events

Proficient in consistent coding of diseases, adverse events, and medication according to the Project-specific coding conventions

Good clinical interpretation skills with strong understanding of medical terminology

Excellent interpersonal communication skills with capable leadership qualities and able to work in fast paced environment with time sensitive materials

EDUCATION:

Masters in Business Administration (MBA)-Healthcare Management

Setonhall University, South Orange, NJ

Bachelors in Medicine & Bachelors in Surgery (MBBS)

Andhra Medical College, Visakhapatnam, A.P., India

PROFESSIONAL WORK EXPERIENCE:

Dr. Reddy’s Laboratories Inc, Bridgewater, NJ (April ’11-Mar ’12)

Drug Safety Associate

Responsibilities:

Generate initial reports by entering information into Drug Safety databases, amend reports and enter follow-up information and prepare report for FDA submission

Completion of literature searches as necessary with completion of the data case entry including narrative and auto-narrative writing

Completion of risk and quality (label, approval, basic manual coding & quality review steps)

Discuss source documents, coding conventions and ad-hoc queries with Medical Physician

Efficiently prepared adverse event reports for medical review and assisted in submission to regulatory authorities, mainly focusing on clinical SAEs

Acted as a liaison between Pharmacovigilance and Clinical Development study teams concerning safety and data reconciliation, protocol development and review, and other functions as necessary

Accomplishments:

Triage of incoming cases to determine seriousness for prioritization of daily workflow

Identified case assessment related problems and reviewed reports

Identified potential product complaints

Performed medical coding using MedDRA and WHO-Drug dictionaries and composed case narratives

Determined follow-up requirements and recommend follow-up

Assisted in preparing NDA and MAA documents in CTD format

A & Z Pharmaceutical, LLC Pittsburgh (Feb ’10- March ’11)

Clinical Safety Specialist

Responsibilities:

Analyzed and extracted the pertinent information from medical records in accordance with legal and US FDA safety regulations

Coded and classified adverse events reports according to Organizational Standard Operative procedures

Performed extensive follow up with the corresponding health care professionals through phone for the best outcome

Clarification of unclear and illegible information from Local Safety officer

Track and log serious adverse events (SAE’s) received from Investigator Sites

Accomplishments:

Confirmation of previously entered data and completion of data entry, including writing adverse event case narrative

Assess expectedness of adverse events and code approval numbers

Forwarded completed case extracts to safety data Coordinator for case initialization

Identify and follow department procedures for AE’s associated with product complaints

Active follow-up via telephone contacts with consumers and health care professionals

Unicam Pharmaceuticals, Goa, INDIA (Sept ’07 – June ’08)

Drug Safety Associate

Responsibilities & Accomplishments:

Basic awareness of drug safety associate accountabilities

Basic case study, evaluating the adverse reactions, coding and finally narrating the case report

Basic knowledge of PSUR-Periodic Safety Update Report

King George Hospitals & Allied Group, A.P., INDIA (Aug ’06 - July ’07)

Clinical Intern, Dept: Various departments of Medicine & Surgery

Responsibilities:

Completing Compulsory Rotatory Medical Internship in King George Hospital, Visakhapatnam, India

Resident physician treating the out-patient & in-patient department

Provided emergency services in trauma care and assisted in monitoring in intensive care unit.

Assessing the seriousness of the case and admitting the patients needing investigations, special care, and treatment

Making detailed notes as a legal documentation of treatment beneficial to other health care providers or professionals

Apollo Hospitals, Visakhapatnam, India (July ’04 – June ’06)

Duty Doctor, Emergency and Out-Patient Department

Responsibilities:

Worked in Cardiovascular Rehabilitation unit admissions of outpatient services admitting patients

Worked as liaison representative between family members and doctor follow up coordination

Designed diagrams and offered presentation regarding development of prudent service of the ICUD

Coordinator for referrals and pre-certification for equipment with physicians

ACADEMIC HONOURS AND MEMBERSHIPS:

Awarded “Gold medal” in pharmacology

General Secretary -Andhra Medical College 2005-06

Life Member Indian Medical Association Andhra Medical Council

Active member of Setonhall Finance club, 2008-10

Active member of International Students Association, Setonhall University, 2008-10

COMPUTER SKILLS:

Operating Systems: Windows 2000, XP, Vista, Windows 7, Macintosh

Statistical Packages: SPSS and SAS

Other: MS Office (Excel, Power-Point, MS Access, Outlook)

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