MANISHA TUMMALA
North Brunswick,New Jersey
Summary
Dedicated and highly organized Medical Doctor with over 2 years of clinical experience and 1.5 years as a Drug Safety Associate. Certified in Advanced Pharmacovigilance and Drug Safety, ensuring compliance with FDA standards and other regulatory authorities. Expertise in signal detection, risk management, and drug vigilance activities, with a strong focus on aggregate reports tracking, including PSUR, PBRER, RMP, and signal detection activities.
Extensive knowledge of Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GPVP), coupled with experience in ICH-GCP guidelines. Proficient in safety database applications, MedDRA, and WHO Drug Coding, with a thorough understanding of 21 CFR Part 11 regulatory requirements. Well-versed in US and EU pharmacovigilance regulatory standards.
Skilled in evaluating, interpreting, and synthesizing scientific data of adverse and serious adverse events, as well as individual case safety reports (ICSRs). Hands-on experience with the Argus Safety Application and comprehensive knowledge of the PV case routing process from case book-in to submission in the Argus Global Safety application. Expertise in MedDRA coding of serious adverse events (SAEs) and adverse events (AEs), and experience in supporting regulatory inspections and audits.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Drug Safety Associate
Sollers
01.2023 - Current
- Responsible for managing the entire life cycle of Safety cases from Initial reporting to close out including Triage Data entry, Assessment, Quality Review, query generation, coding of Clinical Trial and Non-Spontaneous Case reports
- Accurate and timely data entry of both domestic and foreign adverse event information into PSSS (Product Safety Surveillance System) consistent with ARGUS, SOP, process flows, and established time frames within ARGUS workflow
- Responsible for handling the initial receipt of medical inquiries and conducting follow-up for AEs/SAEs
- Full understanding of the product’s Company Core Data Sheet, PI, and IB for accurate labelling and listedness
- Involved in intakes of AEs and book-in via ARGUS
- Performed Benefit- Risk assessment for necessary studies
- Performing thorough documentation of Adverse Event reports , checking completeness and accuracy
- Performed Reviewing of Clinical Trial Protocols, Investigator Brochures
- Hands on experience in receiving the receipt, processing duplicate searches, triage and quality assessment of all inbound safety information including adverse events, reviewing and assessing AEs/SAEs from Initial receipt (Initial Source document) to case closure in Argus database including query generation and case narrative
- Verifies the accuracy, completeness and validity of information for each adverse event report
- Apply MedDRA and WHO Drug Coding Systems to ensure accurate, consistent data entry and analysis
- Involved in MedDRA coding of AEs & SAEs as reported in source documents of reports
- Ensures in compliance with international regulations and guidelines for Drug Safety Monitoring
- Performed regular medical case review for all ICSRs reported from any source including clinical trials, literature, post-marketing studies and post-marketing spontaneous AE reports to ensure complete and timely review aligning with timelines
- Triaged and assessed reported AEs/SAEs and utilize clinical, global regulations to provide causality assessments
- Actively involved in reviewing all AEs and SAEs confirming that events are correctly coded with MedDRA and confirming the seriousness criteria, review of coding products, medical history, indications, adverse events, final quality check of all case content
- Responsible for assessing AEs/SAEs expectedness/Listedness for individual event per Reference Safety Information (RSI) ensuring correct interpretation and application to ICSRs review, case narrative and medical information for completeness, identify missing medical information/data that impact the medical understanding and evaluation of case and issue safety medical queries
- Performed overall case assessment and PV comments on ICSRs as required
- Monitor and follow up on reported safety cases to ensure timely and appropriate action
- Prepare for Regulatory inspections by providing complete documentation
- Collaborate with internal teams for Inspections and Audits
- Ensure accurate and timely submissions to regulators, co-marketing partners and affiliates within company and regulatory timeframes
- Experienced in identifying potential safety signals- Signal detection and Signal Management /Risk mitigation activities at Single Case Level, escalating Product Safety Lead and Medical Monitors
- Support PV related external CAPA findings
- Assisted in processing of all ICSR and Aggregate documents – SUSAR, IND Safety alerts, Six Monthly Line Listings, DSURs
- Review of Aggregate reports- PBRER, PSUR, PADER& , CIOMS and MedWatch Forms
- Knowledge of ICH-GCP and SOPs
- Oversight of external and internal due diligence activities
- Hands on experience in Microsoft Office.
Medical Doctor
Mamata General Hospital
03.2013 - 02.2014
- As a part of my training, I have more than 2 years of Clinical Bedside experience working in ]a Hospital and an additional 1 year of internship as a Medical Doctor
- Knowledge of reviewing Informed Consent Forms and study protocols
- Completed extensive training in Clinical Research
- Conducted initial assessment and screening of patients and treated adult and Pediatric clients under the guidance and supervision of senior medical professionals
- Enroll Patients in Clinical Trials
- Diagnosing the disease as per the symptoms
- Observing and performing the examination of samples for disease diagnose
- Learning the diagnostic methods and equipment’s
- Periodically meeting the patients and observing their improvements and making reports
- Prescribed medications to treat illnesses under proper guidance
- Conducted and monitored Blood transfusions in acute care settings
- Experience in Public Health sciences and Community Medicine
- Experience in assessing the symptoms and treatment plan for Mental illness such as Schizophrenia, Mood, Eating and Personality Disorders
- Monitoring the physiologic variables of Anesthetized patients during and post-surgery
- Assisted senior doctors in Internal medicine department for illness such as Hypertension, Diabetes, Alcoholic liver diseases and Heart diseases
- Hands on experience in incision, drainage of abscess, cysts and other minor surgical procedures
- Experience in assisting major elective surgeries like caesarian section
- Involved in educating the childbearing woman on Family Welfare planning programs
- Performed the Neo-natal assessments, and APGAR Scores for newborn babies in the Pediatric department
- Experience in vaccinating children age ranging from newborn to 5-year-old babies
- Assisted senior orthopedic doctors in POP Cast and dressing of post-surgery patients
- Good Knowledge in assessing patients with Osteo Arthritis and Rheumatoid Arthritis
- Responsible for Monitoring the patients with various hearing disorders, nasal allergies, nasal septum disorders, throat infections, tonsils, and adenoids in the ENT Department
- Hands-on experience in diagnosing visual acuity disorders, cataracts, glaucoma and other retinal disorders
- Experience in performing day-to-day activities in Emergency rooms
- Worked in the Pulmonary medicine department in assessing various chest disorders such as Tuberculosis, pulmonary edema, pneumonia
- Experience in treating various skin disorders like Acne, Dermatitis, Psoriasis, ichthyosis vulgaris, and venereal diseases.
Education
Bachelor of Medicine And Bachelor of Science(MBBS) -
Mamata Medical College
India01.2013
Skills
- Good Clinical Practice (GCP)
- Good Pharmacovigilance Practice (GVP)
- Case Identification
- Drug Safety
- Individual Case Safety Reports (ICSR)
- MedDRA and WHO Coding
- Argus Safety Database
- Regulatory Authority Requirements
- Clinical and Regulatory Writing
- Analytical Skills
- Risk Assessment
- Signal Detection
- Data analysis
Certification
- ADVANCED DRUG SAFETY AND PHARMACOVIGILANCE PROGRAM
- NIDA- ICH GCP Certification.
- Internees Ethics Awareness Programme Certification.
- Basic Life Support Training Certification.
- UMC Certification-Causality Assessment of Single Case Safety Reports, Regulatory Aspects of PV
Timeline
Drug Safety Associate
Sollers
01.2023 - Current
Medical Doctor
Mamata General Hospital
03.2013 - 02.2014
Bachelor of Medicine And Bachelor of Science(MBBS) -
Mamata Medical College
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