Poornima Gaddipati MD
Farmers Branch,United States
Summary
Physician with 5+ years of experience in Safety Reporting, Safety Surveillance and Risk Management for both Investigational and post marketed products. Working understanding of medical concepts and familiarity with safety activities in drug development, drug post marketing and global Regulatory authority requirements. Demonstrated capabilities in: Project management, Time management, Analytical skills, Strong attention to detail and organization Skills.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Pharmacovigilance Scientist /Senior Safety Surveillance Associate
Pfizer
01.2021 - 06.2024
- Expert in reviewing cumulative safety data, with the ability to interpret, synthesize, and communicate complex clinical/scientific information and safety data, alongside developing risk management/mitigation mitigation Strategies.
- Involved in collection and analysis of product safety information from a variety of sources to proactively detect, validate, and assess potential signals.
- Worked closely with the Safety Review Team to analyze and assess safety data using a combination of quantitative and qualitative approaches.
- Participated in Signal management activities such as authoring Signal Evaluation Reports (SERs)
and tracking, documenting, and management of potential and confirmed signals according to
SOPs and guidelines. - Supported safety related activities for clinical trials, including review of protocols, statistical analysis plans, safety content of Investigator Brochures, Informed Consent Forms and clinical study reports as well as performed aggregate safety data Analysis.
- Participated in Aggregate Report management, including strategy, review, and finalization of aggregate safety reports for assigned products, such as PBRERs, PADERs and DSURs.
- Collaborated with Medical Writing to develop timeline and kick-off meeting materials, co-lead kickoff meeting with Medical Writing, document review discussions, review and oversee revisions to produce high quality Aggregate reports according to timelines.
- Supported the preparation and maintenance of safety sections of the Company Core Data Sheet (CCDS).
- Provided safety input to the global regulatory submissions for new indications (e.g. NDA, MAA), in
partnership with safety physician. - Collaborated with Safety Management Team (SMT) for response to safety related queries from regulatory
authorities. - Participated in literature searches and assessments of scientific publications to stay informed about safety information related to Assigned products.
- Collaborated with the Global Risk Management team to develop, implement, and regularly evaluate the EU Risk Management Plan (RMP).
- Contributed to the development and maintenance of PV System policies, SOPs, work instructions, and guidance documents.
- Performed detailed vendor oversight activities for outsourced PV Activities including monitoring of metrics (KPI's), and deliverables from vendor.
Drug Safety Specialist
Merck
05.2018 - 11.2020
- Worked on ARISg for ICSR case processing of reported Adverse Events, including data entry, coding of medical information, writing case narrative and quality review according to applicable regulations, guidelines, SOPs.
- Conducted triage of incoming cases to determine seriousness for prioritization of daily workflow and classify them according to regulatory reporting.
- Ensured duplicate check using Global Safety Database for all ICSR (Individual Case Safety reports) for existing case file.
- Performed Case book in, Data Entry, assessed Seriousness, causality and expectedness using RSI, and QC of all entered data before forwarding case to next workflow. Performed Medical coding using MedDRA and WHODD in accordance with Company Coding Conventions.
- Queries related to safety events are reconciled with data management team and resolved timely.
- Performed Root cause Analysis followed by CAPA for deviations, Suggesting issues in Quality and Compliance.
- Determined and performed appropriate case follow-up including generation of follow-up requests.
- Tracked completion of all assigned trainings by team members.
- Assisted with inspection readiness by ensuring documentation is complete and archived, maintaining archive sites, and conducting other activities as assigned.
- Provided support for audits and inspections.
General Physician/Duty Medical Officer
Nalluri Multi-Specialty Hospital
02.2015 - 11.2017
- Worked as a Medical Doctor in ER and Wards.
- Assessed and accurately diagnosed various disease conditions and provided appropriate medical intervention and treatments to all patients.
- Reviewed and evaluated test results to suggest care and treatment options. Completed patient referrals to other medical specialists.
- Assisted in minor and major surgical procedures, including elective caesarean session and laparotomy, herniorrhaphy, and others.
- Performed peripheral IVs, foley catheters, oral suctioning, NG tube insertions and wound care dressing changes.
Education
MBBS/MD -
Dalian Medical University
Dalian, Liaoning, China.12.2012
Skills
- Signal Detection and Signal Management Activities
- Periodic Safety Update reports/Aggregate reports
- Aggregate Safety data Analysis
- Safety Monitoring for Investigational drugs
- Risk Management Activities (RMP and REMS)
- Therapeutic area - Oncology and Immunology
- Phase 1, 2, 3 and Post marketing
- Benefit-Risk Assessment
- Evaluation of Safety and Efficacy data
- Event Assessment/ Medical Review - Seriousness, Causality and Expectedness
- AOSE
- ICH GCP, GVP Guidelines
- ARGUS, ARISg, Empirica Signal, Veeva
- MedDRA and WHO Drug Dictionary
- Audits and Inspections
- CAPA and RCA
- Combination Therapy
- Products with Multiple Indications
Certification
- Graduate Certificate in Advance Drug safety
and Pharmacovigilance. - ICH GCP Training
Timeline
Pharmacovigilance Scientist /Senior Safety Surveillance Associate
Pfizer
01.2021 - 06.2024
Drug Safety Specialist
Merck
05.2018 - 11.2020
General Physician/Duty Medical Officer
Nalluri Multi-Specialty Hospital
02.2015 - 11.2017
MBBS/MD -
Dalian Medical University
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