Adi Bommareddy
Plainsboro,NJ
Summary
Medical Doctor with 8 years of experience in clinical practice in oncology, 3 years experience in clinical research and development, and 6 years of safety (Pharmacovigilance) experience within the pharmaceutical industry. Possess medical writing skills to produce accurate, concise, medically sound expedited reports. Experience using a drug safety database (ARGUS, ArisG, LSRA, LSMV) to capture adverse events (AE, SAE). Experience working in a post-marketing safety or clinical trial setting (i.e., CRO, pharmaceutical company, and academic setting). Experience working in teams, including supporting other team members when necessary and the ability to lead a team. Strong prioritization skills to ensure that processes, procedures, and best practices are consistent across WWPS and that all applicable regulatory requirements are met in a timely manner with high quality. Ability to make constructive recommendations to improve processes. Demonstrates the ability to multi-task and flexibility to meet changing business priorities. Ability to collaborate within multi-disciplinary teams on drug safety-related issues, including informing safety physicians and scientists within the therapeutic area in case-related matters. Ability to apply sound analytical thinking and database query skills to gather, review, summarize and evaluate critical information promptly. Ability to use medical, scientific, and clinical knowledge in reviewing safety-related documents (e.g., protocols, investigator brochures, product labels, relevant source documents) and incorporating key concepts to clearly present the reported events, and in turn, maintain patient safety. Knowledge and understanding of Health Authority Regulations worldwide, on how to access them and when to refer to them.
Overview
20
20
years of professional experience
Work History
Associate Director, Pharmacovigilance Scientist
Bristol Myers Squibb
Lawrenceville, NJ
12.2021 - Current
- Support Medical Safety Assessment Physicians (MSAP) and lead monthly/ quarterly Safety Data Review Meeting (SDRM)
- Review and evaluation of clinical and safety data to support signal detection
- Partner with SMT Chair on the evaluation & management of signals emerging from any data source
- Author the Safety Topic Review/ Signal Report and track signals for other means of communication, with oversight, as needed
- Perform periodic review and summary of pertinent safety-related literature and analysis of pre-determined core signal data
- Appropriately perform core signal detection activities, execute strategy for signal evaluation (e.g., case-series, literature review, HA/ claims database) and elevate program or portfolio issues impacting key MST programs, priorities, resources, and milestones with appropriate oversight
- Author risk sections of the DSURs, PBRERs and safety data query responses to HAs including coordination and integration of input from other functional groups, as needed to support responses to ad hoc queries, with oversight, as needed
- Author the IB RSI table, with oversight, as needed
- Perform the review and evaluation of SARs for inclusion in the IB RSI, including presentation to SMT to ensure alignment
- Author documentation to support safety labeling updates to ensure labeling adequately reflects the emerging post-marketing safety profile, with oversight as needed
- Review and author SDEA/PVAs in collaboration with cross functional team
- Support preparation for regulatory inspections and audits with evaluation of current processes and assess alignment with regulatory expectations, guidelines, and mandates
- Working knowledge of product goals, strategy, drug development stage milestones, partnership agreement, HA commitments, and individual functional area responsibilities
- Support hiring, orientation and training new hires
- Cross Functional Activities: Support process improvement and cross-functional initiatives for Safety Science including SOPs and Procedural Documents
- Builds cross functional relationships with SMT membership and stakeholders
- Ensure pharmacovigilance regulatory compliance with oversight, as needed general Product Support.
Associate Director, Medical Review and PV
IQVIA
05.2021 - 11.2021
- Performed medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary
- Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
- Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
- Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product’s safety profile
- Provide coding review of AEs, Past medical history, Concomitant medications, or other medical data listings to verify and medically vet clinical data
- Represent safety and clinical data review findings during client meetings
- Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
- Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
- Attend and contribute to medical safety evaluation on Safety Monitoring Committees
- Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
- Perform Medical Safety review of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs) for appropriate safety content and data capture
- Act as Global Safety Physician or Assistant or Back-up on projects as assigned
- Attend project meetings, medical safety team meetings, and client meetings as requested
- Ensure coverage for all medical safety deliverables within regulatory or contracted timelines.
Medical Review Physician
Bristol Myers Squibb
Summit East, NJ
11.2019 - 03.2021
- Safety review of all available safety data generated from various sources (e.g., clinical trial data, post-marketing, literature) throughout the product life cycle for assigned products
- Responsibilities included, medical review of individual case safety reports (ICSR), including summarization, coding, seriousness, expectedness, and Company causality assessment of investigational and/or marketed products
- Reviewed scientific literature for assigned products, identifying case reports that meet criteria for entry into the safety database; identifying relevant safety articles / references involving the active ingredients of the assigned products; and creating literature summary sections for PBRERs/PSURs and other required reports
- Reviewed, and provided input for drug-safety related regulatory reports and clinical study documents (including clinical study protocols, DSUR, PADER, PBRER, PSUR, etc.) and responses to regulatory inquiries
- Supported important medical content of Risk Management documents (e.g., RMPs, REMS) and ensured consistency of safety profile amongst all regulatory documents and reports
- Accrued therapeutic area knowledge to allow ongoing safety assessment within the therapeutic area, including competitive products and therapies
- Supported signal detection activities including detection, monitoring, evaluation, interpretation, and management of safety information emerging from post marketing, literature, and clinical trial data
- Participated in local and/or global departmental meetings
- Maintained compliance with all required training and standard operating procedures (SOP)s.
Senior, Drug Safety Specialist
Celgene Corp.
Summit East, NJ
08.2017 - 10.2019
- Conducted the assessment of all serious individual adverse event case reports stemming from clinical studies, post-marketed and literature sources
- Performed quality control of key data fields and made updates in the safety database (Aris G) as per process conventions
- Executed case assessment (reviewed events, determined expectedness, reviewed/updated drug, and medical term coding (Medra/WHO DD and determined causality)
- Created clear, medically concise case narrative procured from relevant information in form of various source documents
- Drafted pharmacovigilance company comment
- Determined follow-up actions and generated letters/queries as appropriate
- Ensured individual case reports are accurate, complete, and timely for regulatory reporting purposes
- Supported the identification of case corrections and creation of updates in the safety database following medical review
- Executed phone and/or email communication with customers and interdepartmental groups, as necessary
- Worked cross functionally during high workload and served as SME for additional projects such as development products case management (DPCM), data migration, cases leaving assessment workflow (CLAW) and Safety gateways/ Medidata.
Pharmacovigilance (PV) Associate
Shionogi Inc.
07.2016 - 01.2017
- Processed spontaneous post marketing and clinical trials SUSARs/ASE (Analysis of Similar Events Summary) reports
- Prioritized cases based on validity, seriousness, labeling, causality, and event ranking
- Performed medical assessment for cases reported via post marketing programs and spontaneously
- Performed coding for medical conditions using MedDRA and product coding using WHO-DD
- Generated a narrative ensuring quality, detail, clarity, and consistency according to CIOMS template and company’s standard operating procedures as applicable
- Generated and tracked requests for follow-up with investigator sites and physicians for additional/missing information whenever required
- Performed SAE reconciliation.
Drug Safety Physician
Aurobindo Pharma.
NJ
10.2015 - 04.2016
- Performed medical review including verifying the adverse event and drug coding, labeling, reviewing narratives, causality statement, medical aspect of follow-up request, validated follow-up request and performed medical assessment of the case for the Category I and II cases
- Prioritized workload to ensure expedited cases are processed within defined timelines and was responsible for the timely completion of individual cases and met the service level agreements for data entry and case analysis activity as per SOP Approval and the locking of Category I cases
- Responsible for registration in e-logbook and for the duplicate search process
- Ensure quality and timely creation and closure of pharmacovigilance query as per SOP.
Drug Safety Associate
Impax Laboratories
New York
01.2015 - 09.2015
- Processed incoming cases, assessed validity, determined seriousness and expectedness
- Reviewed the events, determined causality and labeling, and developed event ranking
- Performed coding for medical conditions using MedDRA and product coding using WHO-DD
- Composed case narratives with accuracy and precision
- Generated and tracked requests for follow-up with investigator sites for additional/missing information
- Assisted in SAE reconciliation activities.
Clinical Research Associate
Mount Sinai, St. Luke’s and Roosevelt Hospitals
NYC
03.2013 - 11.2014
- Served in Advanced Cardiac Admission Program (ACAP), simplified risk stratification, prioritization, and algorithmic treatment approach, according to guidelines to increase treatment utilization significantly, in patients admitted for cardiac emergencies
- Collected data from CCU and inpatient floors
- Enrolled patients into Advanced Cardiac Admission Protocol (ACAP) - longitudinal prospective registries for admitting diagnosis of Chest Pain & Heart Failure (PAIN Pathway), Syncope (SELF Pathway), Atrial Fibrillation (RACE Pathway) and ESCAPE (EF≤35%) at both St
- Luke`s and Roosevelt Hospital in large numbers of patients, assessing health care provider satisfaction and impact on efficiency
- Contribute in the design of clinical trials, and review trial documents including but not limited to study protocols and amendments, patient information and informed consent forms, study manuals, monitoring plan, progress reports, clinical trials reports
- Maintained all databases
- Collected, cleaned, organized, and compiled data
- Kept projects up-to-date and ensured deadlines where met.
Dept. of Infectious Disease research associate duties
St. Michael’s Medical Center
Newark, NJ
04.2011 - 01.2013
- Screening of potential participants assist with consenting and enrolling of study subjects
- Maintain safety and confidentiality of study subjects all the time
- Assist with data collection, data entry and maintenance of study binder by keeping records, newsletter in appropriate binder section, and assist in completion of regulatory documents necessary to initiate, continue and close clinical trial
- Supervise the completion of enrolling patient, doing histories, physical examination, taking vitals, phlebotomy, performing electronic data capture, and assisting in event of AE, SAE and follow up with subject enrolled in the study
- The primary objective of the research is to assess the safety, tolerability, and the efficacy of different regimens of combination drugs in treatment naïve subjects.
Clinical Externship
Jackson Park Hospital
Chicago, IL
11.2010 - 03.2011
- Worked in inpatient and outpatient settings in various departments, including Internal Medicine, Family Medicine, ObGyn, Emergency Medicine, and General Medicine wards
- Inpatient duties included taking initial history and physical exam, completing concise, thorough, and accurate patient write-up including database, problem list, and patient management plan
- Followed by case presentation during morning rounds and identifying learning issue for each patient
- Reviewed and discussed findings with attending physician and classmates
- Participated in daily follow-up assessments
- Wrote daily progress notes on patients (to be reviewed by the resident or attending)
- Stayed informed on clinical status and test results of each patient
- Learned and performed minor procedures such as venipuncture and arterial blood gases
- Participated in all aspects of attending’s practice: hospital rounds, consultations, nursing home visits, and call
- Attended scheduled rounds and teaching conferences.
Resident Physician
Yashoda Hospitals
Hyderabad
05.2004 - 09.2010
- Worked as postgraduate resident in family medicine
- Actively involved in diagnosis and treatment of a wide variety of common and rare clinical problems
- Worked under supervision of faculty and senior residents
- Performed history and physical examinations on new patients; formulated a working differential diagnosis, and then presented patient to supervisor
- Wrote admission history, physical notes, and discharge summary for each patient
- Responsible for preoperative preparation of patients; provided postoperative care in recovery room or ICU
- Actively involved in teaching medical and nursing students and didactics.
Education
Master’s in health informatics -
University of Illinois
08.2022
ECFMG Certified -
01.2010
MBBS -
Government Medical College
04.2004
Abstracts And Presentations
- Female Gender, Laser sheath use and operator skill drive the success and complication rates of cardiac device lead extraction:” An ACAP registry analysis.
- African- American patients presenting with unexplained syncope have significantly worse outcome compared to other races:” An ACAP-SELF Dataset Analysis.
- Patients with Cardiac Comorbidities Carry the Worst Outcomes as Identified by Our SELF Risk Stratification Pathway:” An ACAP-SELF Dataset Analysis.
- Females with Cardiac Co morbidities Have Worse Outcome Compared to Males Presenting with Unexplained Syncope”: An ACAP-SELF Dataset Analysis.
- Long-term outcome of Patients Admitted with ACS Using Guidelines-based Novel Pathways:” An ACAP- PAIN Five Year Registry Analysis.
Timeline
Associate Director, Pharmacovigilance Scientist
Bristol Myers Squibb
12.2021 - Current
Associate Director, Medical Review and PV
IQVIA
05.2021 - 11.2021
Medical Review Physician
Bristol Myers Squibb
11.2019 - 03.2021
Senior, Drug Safety Specialist
Celgene Corp.
08.2017 - 10.2019
Pharmacovigilance (PV) Associate
Shionogi Inc.
07.2016 - 01.2017
Drug Safety Physician
Aurobindo Pharma.
10.2015 - 04.2016
Drug Safety Associate
Impax Laboratories
01.2015 - 09.2015
Clinical Research Associate
Mount Sinai, St. Luke’s and Roosevelt Hospitals
03.2013 - 11.2014
Dept. of Infectious Disease research associate duties
St. Michael’s Medical Center
04.2011 - 01.2013
Clinical Externship
Jackson Park Hospital
11.2010 - 03.2011
Resident Physician
Yashoda Hospitals
05.2004 - 09.2010
Master’s in health informatics -
University of Illinois
ECFMG Certified -
MBBS -
Government Medical College