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Medical Safety

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Posted:
March 24, 2021

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Resume:

CURRICULUM VITAE

DR. SRIVIDYA EMINENI

Hyderabad, Email: adk4xs@r.postjobfree.com

Telangana. Mobile: +91-702*******

Academic Profile

Education

Institution

Month/Year of passing

Percentage of Marks

MBBS

Zaporozhye State Medical University, Ukraine, Europe

May, 2012

75

Intermediate

Sri Chaitanya Junior College, Hyderabad

Mar, 2006

86.6

SSC

Sri Krishnaveni Talent School, Hyderabad

Mar, 2004

88.5

attributes

-Passed the Screening test for the Foreign Medical Graduates (FMGE) conducted by National Board of Examination (NBE) on 30th September 2012.

-After completion of rotatory internship in Guntur Medical College got registered as a medical practitioner in India with Registration number: APMC/FMR/8873 from Andhra Pradesh Medical Council in Hyderabad dated 13th October 2014.

-Participated as the medical team member in the army recruitment camp.

-Undergone training for BLS (basic life support).

-Participated in the survey in a village on smoking.

-Participated in free checkup camp for the poor people in many villages.

-Currently working as Medical reviewer/Aggregate Safety Review Physician at Accenture, Bangalore

Work Experience

Senior Medical Safety Expert, Novartis Healthcare Pvt Ltd (From 11 March 2019 to present)

job description:

Provide support to the Medical Safety Therapeutic Areas according to the needs for delivery activities, i.e. ICSR Medical review; co-authoring safety documents, assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries. Provide support to the TAs Safety Leads by creating quality deliverables within agreed timeframes and adhering to a high standard of accuracy in compliance with Patient Safety business rules, standard operating procedures and global and local regulatory requirements.

Description of responsibilities handled-

-Provide support to TA according to the needs for delivery activities, i.e. ICSR Medical review; co-authoring safety documents and assisting in providing safety input to regulatory and clinical documents, as well as ad hoc Health Authority queries.

-Assist TA Safety Leads in monitoring the safety profile of products including with activities such as literature review, medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects or signal detection. Medical review of single case reports will be performed by associates possessing medical degree.

-Perform Literature review for PSUR inclusion and assessment of literature for ICSRs.

-Provide support for the preparation of ad hoc Health Authority queries for TA, provides input into responses to inquiries from health care professionals on safety issues.

-Together with the Safety Leads under minimal supervision, co-author and medically review the PSUR sections, including analytical input to PSUR for identified and potential risks defined in the Risk Management Plan (RMP) and new safety signals. Perform follow up activities on Health Authority Assessment Reports.

-Assist in providing safety input to Regulatory Affairs and clinical documents (for CDS and IB RSI), support maintenance and management of local deviations (SMPC, USPI, Japanese PI).

-Assist in evaluating and writing other safety deliverables including but not limited to Clinical Overview, Development Safety Profiling Plan (d-SPP), and Development Safety Update Report (DSUR).

-May deputize for PVLs as agreed with the Head Medical Safety Expert Office.

-Provide safety input (Addendum to Clinical Overview) for license renewal documents.

-Provide support as needed for new indication submission (regulatory document safety input).

-Co-author medical assessment of product quality issues.

-Facilitate the preparation of Product Guidance Documents (PGDs) for marketed products.

-Contribute to the development and update of RMPs in collaboration with Safety Leads coordination with other functions, and tracking.

-Prepare responses to internal safety requests and contribute responses to external safety queries

-Act as Subject Matter Expert (SME) and process owner for Medical Safety Expert Office/Medical Operations/ Medical Function (participation in initiatives).

-Lead the training and mentoring of junior Medical Safety Experts.

Drug Safety Physician (Product Safety and Risk Management), Mylan Pharmaceuticals Pvt Ltd From 29 Dec 2017 to 28 Feb 2019.

job description:

Acting as a Safety Surveillance and Risk Management Medical Reviewer:

- Responsible for assisting in Periodic Safety Update Reports (PSUR) and Addendum to Clinical Overview (ACO), DSUR etc. related activities (including but not limited to report writing & medical review, handling of requests received from Central & Local Regulatory Affairs and PV departments) within respect of timelines and any other related task.

- Responsible for assisting in Risk Management Plans (RMP) related activities (including but not limited to collection of data, RMP writing and medical review, handling requests received from central or local regulatory affairs and PV department, preparation of risk minimization measures and evaluation of effectiveness of same) within timely manner.

- Signal Detection -Medical review of signal reports including detection, evaluation and assessment.

- Health Authority Responses- Assist in preparing or preparing responses to Regulatory Authority questions related to safety issues and conducts medical review

- Responsible for providing medical comments/ opinion on- Safety information in labels, CCDS or RSI.

- Assisting in any other Pharmacovigilance projects, as necessary

- Providing medical safety expertise and training to other personnel, as necessary

- Keeping current with professional and pharmacovigilance regulations and knowledge

- Providing medical guidance to team members in medical aspects of drug safety and any other Mylan personnel

- Assisting or overseeing any other project where SST is involved, as deemed necessary

Medical Services Senior Analyst, Accenture solutions India Ltd From 05 Oct 2015 to 24 DEC 2017.

job description:

1.Responsibilities as medical reviewer:

-Reviewing and verifying appropriate selection of adverse events from source documents, appropriate MedDRA code for each adverse event and accuracy of label assessments for each adverse event.

-Providing a medical evaluation comment for all serious spontaneous, unlisted adverse events and serious related events from studies and solicited adverse events.

-Providing causality assessment whether the drug is capable of causing a particular adverse event based on:

Pharmacology and previous knowledge of adverse drug reactions.

Association (time and place) of adverse event and drug.

Likelihood or exclusion of other causes.

Analysis of everything in report and note what data are not in report.

-Providing assessment(s) for study cases and solicited reports.

-Reviewing the source document to assure relevant information pertaining to the case is appropriately entered.

-Verifying consistency between source documents and narrative summary.

-Attaching/ reviewing all letters and queries for appropriateness and completeness.

-Assisting in training for new resources and as a part of continuous improvement.

-Interacting pro-actively within and across areas to facilitate system and process improvement.

-Leading and participating in team meetings.

-Ensure compliance with client and company policies.

-Own assist and comply to all SLAs (Cycle time and quality)

-Currently assigned to therapeutic areas Ophthalmic, Respiratory, Cardiovascular and Central nervous system

2.Responsibilities as Aggregate safety report physician:

-Responsible for medical review of the aggregate report within agreed timeframes and to a high standard of accuracy, standard operating procedures and global regulatory requirements.

-Prepare and perform medical review for the safety sections of the aggregate report.

-Ensuring the Periodic Safety Update Report (PSUR) is medically relevant, complete, consistent and accurate.

-Causality assessment and writing medical assessment comment.

-Review and finalize narratives.

-Actively participates in Kick-off-Meeting (KOM), project planning/strategy making meeting.

-Ensuring that the safety issues are adequately addressed in the aggregate document.

-Ensure that all the Health Authority (HA) comments from previous PSUR assessment report are adequately addressed in the current PSUR.

-To discuss and provide analysis for current review period and cumulatively, including adverse drug reactions reported spontaneously and published literatures.

-To review and provide any noteworthy cases for the current review period

-Review the late breaking Argus information, discuss with Novartis medic and address in the document as appropriate.

-To review and provide medical comments for published studies including pregnancy registries.

-To discuss and provide analysis for drug interactions, overdose, drug abuse/misuse, pregnancy/lactation, special patient groups and medication errors.

-To provide the final conclusion regarding the current safety profile of the product.

-Responding to medical queries raised by the Novartis Single Point of Contact (SPOC)/Pharmacovigilance Expert (PVE)/Pharmacovigilance Leader (PVL/ Brand Safety Lead (BSL) and provides feedbacks.

-Reporting to the Manager on report status and any escalations

Duty doctor, From 01 November 2014 to 25 September 2015 in jaya hospital, guntur.

job description:

- Undertaking patient consultations, physical examinations, taking patient history, admissions and treatment orders as per initial management of acute emergencies.

- Providing general pre and post operative care.

-Monitoring and administering medications.

Intern, Guntur General Hospital from 1st January 2013 to 31st December 2013

Job description:

-Assisting the senior doctor in checking the patients.

-Diagnosing the disease as per the symptoms.

-Observing and performing the examination of samples for disease diagnose.

-Learning the diagnostic methods and equipments.

-Performing basic duties like checking the BP, sugar, etc.

-Observing them while performing their duties.

-Assisting to them in surgery.

-Performing patient’s checkup under guidance of senior Dr.

-Checking the reports of patients.

-Periodically meeting the patients and observing their improvements and making reports.

-In case of emergency giving the basic treatment to the patients.

-Helping other medical staff in performing their duties.

Strengths

-Good interpersonal skills and Good communication skill

-Excellent theoretical knowledge and Good knowledge of clinical practices and protocols.

-Ability to handle different types of patients in critical situations.

-Flexible and adaptable and quick learner

-Extremely motivated towards career.

-Good motivating skills, Can work under pressure.

Personal Profile

Father’s name: E.S.N Rao

Gender: Female

Date of Birth: 24-09-1989

Nationality: Indian

Languages Known : English, Telugu, Hindi and Russian

Declaration

I hereby declare that the information provided above is true to the best of my knowledge.

Place: Bangalore

(E. Srividya)



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