Quality Assurance Safety

Srikanth K

E-mail: *******@*****.***

Phone: 815-***-****

OBJECTIVE

Highly competent and focused healthcare professional looking for a clinical safety specialist position in drug safety, where I can acquire new skills and achieve my goal by utilizing my experience and credentials in case processing, narrative writing and validation skills for further professional growth.

SUMMARY OF SKILLS

• A combination of 5 year experience as drug safety associate, clinical & safety associate and medical products associate with experience of processing and submissions of single case processing reports, and submissions of NDA’s and ANDA’s.

• Ability to follow ICH, FDA guidelines, GCPs, GLPs, standard operating procedures and safety guidelines

• Proficient in data entry and drug safety databases.

• Experienced in handling and processing adverse event reports for investigational and marketed products in numerous scientific approaches.

• Broad understanding and experience in case processing of spontaneous and study cases.

• Experienced in working in a cGMP and GLP environment.

• Ability to work in a fast paced organization and maintains time lines for multiple projects.

• An effective communicator at all levels within the organization.

EDUCATION

Governors State University, Chicago, IL Aug’ 10

Masters in Analytical chemistry

Coursework Included: Chromatography, Organic Spectroscopy, Inorganic spectroscopy, Method Development, Pharmaceutical analysis, Environmental chemistry, and Electro chemistry.

Chalapathi Institute of Pharma Sciences, A.P, India. May’ 08

Bachelors in Pharmacy

Coursework Included: Clinical pharmacy, Pharmacology, Pharmacokinetics, Therapeutic drug monitoring, Forensic pharmacy, Pharmaceutics, Pharmaceutical analysis, Medicinal chemistry, Industrial pharmacy, Organic chemistry, Inorganic chemistry and Pharmacognosy.

EXPERIENCE

Baxter Pharmaceuticals, Chicago Sep’ 11 – Feb’12

Associate, Medical Products

• Writing and issuing specifications for evaluated methods.

• Review and approve protocols and reports related to analytical methods, analytical method transfer, and reference standards as assigned.

• Prepare and conduct training on Quality systems as required. Provide technical consulting in area of expertise to groups within and outside of MP R&D.

• Assure compliance of reports to regulatory standards.

• Review and provide input to harmonization initiatives as required.

• Participate in assessments/audits to assure compliance with Quality system requirements. Support both internal and external audits.

• Report on performance of Quality systems through management review processes, metrics reporting, and scorecard reporting.

• Maintaining quality and validated documents.

• Maintaining open lab and BPLM systems up to date.

• Experience in the Iso-train management.

• Maintain open communication with study directors to facilitate problem resolution.

InvaGen Pharmaceuticals, New York Jan’ 10 - Aug’ 11

Clinical & Safety Associate

• Participation in the collection, safety review, processing and reporting of adverse events data in compliance with applicable FDA and global regulations and company Standard Operating Procedures (SOPs) and guidelines

• Triaged incoming cases to determine seriousness processing and report prioritization.

• Promptly and accurately interpret and enter both serious and non-serious adverse events into the global database for distribution.

• Accurate coding of incoming serious and non-serious adverse events using MedDRA terminology.

• Created comprehensive narrations for cases from relevant information of various source documents in accordance with departmental process

• Assess follow-up, lock, and distribute/archive non-serious cases.

• Assist in the development and evaluation of new HPLC methods.

• Writing and reviewing the Standard Operating Procedures.

• Adhering to company templates and guidelines for documentation and communications

• Validating analytical testing methodology for raw materials, intermediates and finished products.

• Writing the technical reports for documenting the analytical methods for QC department.

• Expertise in handling the OOS and laboratory deviations.

• Performing quality control activities to ensure complete and accurate case information has been entered into the safety database.

• Instrumentation use: HPLC, GC, PDA, KF titrator, Polarimeter, Dissolution apparatus, and UV-Visible Spectrophotometer.

Intertech Labs, Hyderabad, India Feb’ 06 – Feb’ 08

Drug Safety Associate

• Responsible for collection, documentation, and evaluation of adverse events information from different sources.

• Reviewing and processing initial and follow-up information for both serious and non-serious adverse events in safety database by producing a narrative using the appropriate narrative template and coding adverse events, suspect products and concomitant products using Med DRA and WHO-Drug dictionaries within defined reporting timelines.

• Assisting in tracking information regarding potential adverse events submitted by all reporters including consumers, healthcare professionals, co- manufacturers, call centers, medical information, quality assurance and other company representatives accurately within defined reporting timelines.

• Processing and assigning cases in the validated database by performing assigned roles (data entry, safety processing, and safety reporting) within Global and local timeliness.

• Reviewing the appropriate selection of adverse events from source documents, appropriate Med DRA code and seriousness for each adverse event and accuracy of label assessments for each adverse event.

SEMINAR AND RESEARCH PAPERS PRESENTED

• Keynote speaker in seminar on DRUG-DRUG interactions & ANTI-BACTERIALS.

• Author for paper titled “Formulation and in-vitro evaluation of Diclofinac Sodium sustained release tablets in international journal of chemical sciences.”

MEMBERSHIPS

• Member of Indian Pharmaceutical Congress.

• Member of Indian Pharmaceutical Graduates association.

• Member of American Chemical Society.

• Member of American Association for Clinical Chemistry.

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