Medical Safety

Dr. Padmaja Konduru

Phone: 714-***-**** E-mail: ************@*****.***

Summary:

Clinical healthcare professional (Medical Doctor) with expertise in processing adverse event reports for investigational and marketed products in numerous scientific approaches.

Medical Doctor with both clinical, and pharmacovigilance knowledge and skills.

Proven record of success in the extraction and submission of reports required by the regulatory authorities.

Thorough understanding of US/EU/AP/LA regulations and ICH guidelines (global regulations).

Good knowledge of coding with MedDRA and WHODD.

Experience in safety database – ARGUS.

Expertise in reviewing, evaluation and summarizing the data – Case narration.

Collected and extracted relevant information from medical charts, conducted safety review, processed and reported adverse events data in compliance with applicable FDA and global regulations and company Standard Operating Procedures (SOPs) and guidelines.

Good knowledge of clinical research.

Knowledge of medical terminology and transcriptional abilities imbibed over the educational period.

Healthcare professional with over 8 years of experience in clinical practice.

Strong knowledge of case processing of study and post-marketing reports.

Strong orientation, creative and conceptual thinking required related to reports and case investigations.

Managerial experience training, giving medical expertise and evaluation of associates, coordinators and other cross functional teams.

Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and leadership and influencing skills.

High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a “player/coach” as necessary.

Ability to interact effectively with professional and non-professional staff and clients.

Computer professional having good command on complete suite of MS Office, and other software used as per the requirements within the company.

Ability to work in a fast pace environment, manage priorities, and maintain timelines for multiple projects in both a team/matrix environment as well as independently.

Skill:

Drug safety/ Pharmacovigilance

Adverse event reporting

MedDRA, WHODD coding

Safety database – ARGUS

Post-marketing reports

Global regulations

Operating Systems:

Windows 2000, XP, Vista, Windows 7, Macintosh

Statistical Packages:

SPSS and SAS

MS Office

Word, Outlook, Excel, Power-Point, Publisher

Education:

MD, Internal Medicine Oct97 – Jun03

Kazakh National Medical University

Experience:

4C Pharma Solutions. Piscataway, NJ Feb14 – Mar15

Drug Safety Associate

Collected and extracted relevant information from medical charts, conducted safety review, processed and reported adverse events data in compliance with applicable FDA and global regulations and company Standard Operating Procedures (SOPs) and guidelines.

Executed receipt of Drug Safety phone calls and completed telephone AE form.

Created phone call communication logs in central safety database.

Supported the triage of cases conducted by Sr. Specialist or designee as needed.

Created key fields updates in central safety database based on QC, as needed.

Constructed case narrative to summarize all relevant medical information for the adverse event(s) following current case processing and narrative conventions, reviewed events as captured in source documentation, prioritized case reports and implemented expedited process when applicable.

Created auto-narrative as needed for non-serious cases, and then reviewed and updated auto-narrative as needed.

Developed event rankings, created dechallenge / rechallange determinations.

Developed follow-up needs for AE reports and created targeted question follow-up letters, and reviewed and updated generated follow-up letters as appropriate.

Participated in product meetings within the drug safety department.

Ramesh MD, Pottstown, PA Jan12 – Dec13

Worked as an Assistant

Performed/directed patient care services including, but not limited to, admission interview, accurate documentation and timely patient flow.

Ensured priority care is provided to patients in an emergency situation.

Ensured patient is appropriately prepared for care encounter.

Prepared/obtained patient medical records and other information/documentation pertinent to patient encounter.

Assisted healthcare providers with exams, treatments, procedures and testing as directed-ensured appropriate consent forms are obtained prior to the above.

Scheduled and provided patient instructions for tests, treatments and hospital admissions, following correct insurance protocol (Pre-certification, referrals, chart documentation, etc.).

Provided patient and family education pertaining to healthcare management, disease process, treatment, tests, medication and follow-up.

Maintained/updated patient education materials and consent forms.

Received, prioritized, documented and responded to incoming calls as appropriate.

Notified patients of lab and diagnostic test results.

Assisted taking patient history and vitals.

Rathna Nursing Home, India Mar10 – Oct11

Attending Physician

Worked as a physician and was responsible for day to day activities from seeing the patients to make sure that they get required treatment and diagnosis on time.

Prescribe or administer treatment, therapy, medication, and other specialized medical care to treat or prevent illness, disease, or injury.

Order, perform, and interpret tests and analyze records, reports, and examination information to diagnose patients' condition.

Collect, records, and maintain patient’s information, such as medical history, reports, and examination results.

Monitor patients' conditions and progress and reevaluate treatments as necessary.

Explain procedures and discuss test results or prescribed treatments with patients.

Advise patients and community members concerning diet, activity, hygiene, and disease prevention.

Refer patients to medical specialists or other practitioners when necessary.

Eagleville Geriatric Psychiatric Hospital, Eagleville, PA Jul09 – Feb10

Clinical Specialist

Collaborated with clinic staff to provide efficient, accurate and courteous service for patients

Ensured correct and accurate procedures are performed on patients and provides timely collection and preparation of specimens for laboratory testing for all clinic patients

Communicated appropriately and effectively with employees and all associated departments

Assisted patients by providing information, services and assistance

Performed administrative front and back office tasks including, but not limited to, chart preparation and appointment scheduling.

Nova Healthcare, Fairfax, VA Mar08 – May09

Medical Assistant

Performed/directed patient care services including, but not limited to, admission interview, accurate documentation and timely patient flow.

Ensured patient is appropriately prepared for care encounter

Prepared/obtained patient medical records and other information/documentation pertinent to patient encounter.

Assisted healthcare providers with exams, treatments, procedures and testing as directed-ensured appropriate consent forms are obtained prior to the above.

Scheduled and provided patient instructions for tests, treatments and hospital admissions, following correct insurance protocol (Pre-certification, referrals, chart documentation, etc.)

Provided patient and family education pertaining to healthcare management, disease process, treatment, tests, medication and follow-up.

Maintained/updated patient education materials and consent forms.

Received, prioritized, documented and responded to incoming calls as appropriate.

Notified patients of lab and diagnostic test results.

Howard University Hospital, Washington D.C. Metro Area Nov07 – Feb08

Clinical Specialist, Cardiology Dept.

Prepared and maintained daily medical records and lab reports.

Volunteered in Cardiology department lab.

Worked with customers to do evaluations and consultations or obtain complaint information.

Followed up on previous evaluations and conversions or complaints that requires additional information.

Established relationships and built confidence among lab staff, physicians, representatives, and customers.

Ensured clinical details involving customer complaints are documented.

Attended meetings to help determine which events/incidents require notification to regulatory authorities.

Liaised between the lab/customers and representatives.

Conducted assessment testing to ascertain the skill level and ability of those individuals being trained, and develop training curriculums and programs to improve knowledge, skill, and ability.

Conducted ongoing staff training and provide clinical feedback to resolve customer related issues.

Observer Physician Mar05 – Oct07

Plastic surgeon: Dr. Raghava Raju, MD

Provided systematic care to patients in hospital wards as well as in outpatient clinics.

Participated in inpatient and outpatient rounds, core conferences, lectures and learns about integrative, high quality medical care.

Had inpatient and outpatient experiences, in various subspecialties; met interests and professional development needs.

In addition to inpatient and outpatient rounds, attended didactics - morning reports, noon reports, grand rounds, and clinical case discussions.

Experienced on medical knowledge, clinical reasoning, and communication skills.

Rathna Nursing Home, India Jun03 – Feb05

Attending Physician

Performed patient care services including, admission interview, accurate documentation and timely patient flow.

Ensured priority care is provided to patients in an emergency situation.

Ensured patient is appropriately prepared for care encounter.

I was exposed to wide variety of cases in all departments. I was assigned to a particular number of in-patients and was expected to take full responsibility and report back to our doctors. I would take a detailed history and physical examination once the patient was admitted and would order the primary diagnostic tests required for the case. I would attend daily rounds to make notes on patient’s condition. I was given many opportunities to do such as, nasogastric intubations, catheterizations and CPR's under the guidance of the senior doctors.

Prepared/obtained patient medical records and other information/documentation pertinent to patient encounter.

Assisted healthcare providers with exams, treatments, procedures and testing as directed-ensured appropriate consent forms are obtained prior to the above.

Provided patient and family education pertaining to healthcare management, disease process, treatment, tests, medication and follow-up.

Maintained/updated patient education materials and consent forms.

Received, prioritized, documented and responded to incoming calls as appropriate.

Notified patients of lab and diagnostic test results.

Kalkaman hospital in Almaty Sep02 – May03

Resident Physician

Supervises and provides systematic care to patients in hospital wards as well as in outpatient clinics.

Admit the patients needing investigations, special care, and treatment.

Examine and discuss with patients in order to diagnose their health conditions.

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

Undertake managerial duties like staffing the unit, planning the workload, particularly at senior levels. Working with senior or junior doctors as a team member, either in the same personnel or within other specializations.

Liaisons with other non-medical and medical faculty in the hospital to guarantee high quality treatment.

Participate actively in the orientation programs of new faculty to organization’s policy, philosophy, health center functions, and procedures to encourage effective teamwork.

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