Data Entry Manager

Mounica

Contact: 248-***-****

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

SUMMARY:

4+ years of Work Experience

Highly skilled and competent healthcare professional with experience in Pharmacy.

Extensive knowledge on analytical and statistical back grounds.

Can perform all necessary duties in the community pharmacy for an optimum workflow.

Hands on experience in Data entry, case processing, MedDRA coding, and narrative writing.

Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations.

Familiarity with the drug development process during clinical trials.

Knowledge on submission criteria, regulatory timeline requirements, technical requirements, and guidelines for reporting of SAE to regulatory authorities.

Strong knowledge of quality management procedures and compliance monitoring.

Skilled in technical and general communication, both in writing and verbally.

Excellent communication, analytical, interpersonal and presentation skills.

WORK EXPERIENCE:

Thermo Fisher Scientific, New Jersey (Nov2018 – Current)

QC Chemist

Responsibilities:

Testing samples in accordance with established procedures and using all instrumentation required in the procedures, including AA, LC, GC-FID, GC-ECD, GC-MS, IR, ICAP, UV-VIS, Melting point apparatus, Karl Fisher.

Testing samples using wet chemistry technique.

Segregate, label and dispose of waste chemicals in accordance with company, local, state and federal regulations and assist in reducing waste.

Maintaining Efficiency, productivity and Integrity with analytical data to meet required standards.

Assisting in continuously updating standard operating procedures.

Reviewing test data prior to releasing in Thermo Fisher system according to the procedure.

Prepare reagents and standard solutions and standardize according to requirements.

Performing elementary method analysis and development for troubleshooting purposes. Make recommendations to technical support on analytical methods.

Repair, maintain and calibrate laboratory instruments.

Assist with resolution of Investigations, customer complaints and reviewing batch records.

Knowledge and experience of Lean Six Sigma Process and support continuous improvement activities.

Blue Cross (Michigan) (July2017- October2018) Biostatistician

Responsibilities:

Perform or supervise complex statistical analyses and create or provide input to statistical reports – usually in English

Assist the Manager and Sr. Director in defining and maintaining departmental standards, SOPs and working practices

Stay current with new developments in statistics, drug development and regulatory guidance through literature review, conference attendance, etc

Provides input for pooling strategies for submissions and IND updates, and provides statistical input into the Investigator Brochure

Evidence of strong teamwork in order to successfully work with a trial team and project level team members

Leads and manages the technical operations of assigned projects and provides technical guidance and mentoring to the project team

Develop complex analysis strategies, and execute them using efficient programming techniques (software: SPSS)

Burlington Pharmacy (March 2017-June2017) Intern, Part-Time

Responsibilities:

Assisting the pharmacist to maintain inventories of medications and the prescriptions.

Ensure that the information on the prescriptions is accurate.

Entering client information in the database and fill the prescriptions.

Compounding oral solutions, antibiotic suspensions, ointments, and creams.

Bill third party insurers

CDSCO, Delhi, India. (Sept2015 - March 2017)

Senior Data Associate

Responsibilities:

Handling of SAE-Death and Injury reports and writing medically relevant safety narrative of cases and checking for the completeness of the case.

Causality assessment of the events and its relatedness to the investigational product/trial.

Verification of the information/documents submitted by Sponsor, Investigator and Ethics Committee to make sure that the submission of data was done according to Schedule Y of D&C act, 1940 and identification of protocol deviations or any scientific misconduct in the trial.

Deliberation of the cases to qualified medical professionals in Independent Expert.

Committee meetings and preparation of the recommendations as per their suggestions.

Calculation of the compensation to pay to the subject/legal heir/nominee as per 122 DAB and Appendix-XII of Schedule Y to Drugs & Cosmetics rules 1945, in case SAE related to the Investigational product/ clinical trial.

ADDITIONAL SKILLS:

Expertise in SPSS.

Excellent skills in using all Microsoft products.

Certified in performing CPR.

Excellent communication and leadership skills.

Education:

PharmD & master’s in public health

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