Drug safety Associate

VANDANA GOSWAMI

Address: *** ******* **** **, ****, NC,27518

Contact: 919-***-****

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

OBJECTIVE

To seek a challenging career in the pharmaceutical industry that will allow

me to contribute to the growth of the company while building upon my skills

and leadership ability.

SUMMARY SKILLS

. Knowledge of ICH-GCP, FDA and EMA guidelines

. Knowledge of scientific terms and medical terminology

. Knowledge of working on databases Clintrace, ARISg, Oracle AERS

. Knowledge of MedDRA and E2B submissions

. Able to work in an environment of rapidly changing priorities

. Able to work both as a member of a team and in an independent, self-directed manner

. Able to manage and organize work to meet timelines

. Excellent verbal and written communication skill

. Proven interpersonal, organizational skills and analytical thinking

. Excellent knowledge of Microsoft word, Excel and PowerPoint

WORK EXPERIENCE

Pharmacovigilance Associate

(October 2010-Dec 2012)

Pharsafer Associates Ltd. United Kingdom

Responsibilities:

. To process the safety reports received from clinical trials and post marketing sources for assigned products and report according to the ICH-GCP guidelines, regulatory requirements, company's SOPs and procedures.

. To monitor incoming case reports, queries in the drug safety inbox and send notification and acknowledgement emails.

. To coordinate and perform triage, case evaluation, tracking of case reports, data entry, and medical narrative creation.

. To perform coding of diseases and adverse events by using MedDRA.

. To perform coding of medications.

. To assess case reports for seriousness, expectedness/listedness and causality in accordance with regulatory guidelines and productlabelling.

. To perform peer quality control of the cases for quality, consistency, accuracy and completeness of information as entered into the safety database.

. To receive and process product quality complaint cases and forward the case reports to quality assurance department for investigation.

. To conduct follow up of cases with reporters; consumer or associated HCP for missing information/source documentation with required standards of quality and timeliness.

. To work with assigned physicians to ensure that appropriate medical review and assessment is provided for assigned case reports.

. To identify cases requiring expedited reporting according to applicable requirements includes both paper based and electronic reporting.

. To produce CIOMS/ MedWatch forms for the case reports.

. To assess the CIOMS/MedWatch forms for submission and perform E2B submission and paper based submission to global regulatory authorities and the sponsors with the applicable guidelines and

statutory timelines.

. To maintain tracking records for expedited reporting and EVWeb acknowledgements.

. To maintain accurate and comprehensive hard copy and electronic files for initial and follow up cases as per legal requirements.

. To assess the adverse reactions from case reports for potential signals and signal detection.

. To review weekly search of literature articles/abstracts for ADR/PSUR/SSR reasons and process adverse event reports from literature articles as per regulatory requirements.

. To write summary sections from literature articles for PSUR.

. To review aggregate safety data from the database and generate line listings and necessary data queries.

. To provide medical information regarding the specific company products for excipients, product use, side effects and providing SPC and also tracking and creating the case reports for company's

product.

. To perform the reconciliation of the case reports received.

. To review SOP for new regulations and guidelines and produce updated version with respect to new legislations.

. To perform compliance matrices for client and company review.

. To assist with pharmacovigilance training of new starters.

. To identify the potential safety, quality and regulatory issues and to bring to the attention of manager.

. To keep all processes and data ready for an inspection at all times.

. Participation in internal and external audits and inspections by clients and health authorities.

Research Assistant

(2006-2008)

Guru Nanak Dev University, India

Project Title: To detect the possible role of reactive oxygen species (ROS) in changing

the expression of genes by signal transduction in Arabidopsis thaliana.

Responsibilities:

. To treat Arabidopsis thaliana for artificial production of reactive oxygen species.

. Measurement of ROS by SOSG fluorescence imaging.

. To collect and store the treated samples.

. Isolation and extraction of RNA from collected samples, DNA digest,quantification cDNA synthesis, electrophoresis, PCR, qRT-PCR, gene expression.

. To record the data in a record notebook, analyse it and present during the weekly lab meetings.

. Prepare, collate and present data in an understandable manner to members of the research group at regular group meetings.

. To prepare stock solutions and buffers for the lab.

. Provide flexible technical support to members of the research group based on their needs.

EDUCATION

MSc Clinical Biochemistry

(2008-2010)

University of Surrey, Guildford, UK

Subjects: Introduction to Clinical Biochemistry, Haematology and

Transfusion Science, Immunity and Principles of Clinical Immunology,

Genetics and Clinical Molecular Biology, Analytical Methods I, Analytical

Methods II, Clinical nutrition, Pathophysiology, Medical biochemistry,

Enzymology, Toxicology and Lipidology

Dissertation:

Objective: The main study objective was to investigate the effects of the

different fibres (soluble, insoluble and control) on both fasting and post-

prandial blood samples in adult men and women, specifically analysing

changes in the inflammatory markers; CRP, vWF and tPA-1 of CVD risk.

Responsibilities:

. Detailed study of ICH-GCP guidelines, study protocol, consent form

versions and compliance

. Study of subject counselling, informed consent administration,

screening and randomization.

. Study of subject visits and study procedure as per protocol and sample

collection.

. Measurement of the plasma levels of CRP, vWF and tPA-1 by using ELISA

. Data collection, record keeping and statistical analysis

MSc in Life Sciences

(2003-2005)

Guru Nanak Dev University, Punjab, India

Bachelors of Sciences

(2000-2003)

Punjab University, Punjab, India

VOLUNTARY WORK

Outreach staff member

(2010)

British Heart Foundation, United Kingdom

. Interact with various community people and create awareness on heart

diseases

. Motivate people to sign up with British heart foundation and to avail

the benefits

PERSONAL VITAE

Interests and Hobbies: Drug Safety, clinical research, sports and

travelling.

Additional Information: Possess valid work permit (EAD).

Contact this candidate