Priyanka Thakur Drug Safety Specialist(Willing to relocate on her own dime)

Registered nurse with 8 years of experience which includes 5+ years of in the Pharmacovigilance domain and over 3 years of clinical experience. Responsible for overseeing specific aspects of adverse event processing and reporting for assigned investigational and marketed products. 

SUMMARY OF THE EXPERTISE: In depth Knowledge in various types of case processing including clinical, spontaneous and literature.

Experience with Clinical Trials, Post-Marketing Individual Case Safety Reports (ICSRs), Medi-cal Device Reports and Regulations.

Expertise in Preparation of Periodic Safety Reports (PBRER, DSUR) including coordination of the different functions concerned, review of literature, data analysis and identification of safety con-cerns.

Responsible for Triage of adverse event reports including review and prioritization of adverse event and other product related information submitted to the company from clinical trial investigators, health care professionals and consumers.

Worked with the clinical project team to ensure consistency in the assessment, recording and coding of clinical safety events (e.g., SAEs, adverse events (AEs), and device deficiencies), worked with Regulatory Affairs, Clinical Operations and Field Assurance to ensure timely reporting of AEs, SAEs and UADEs including expedited and annual reporting.

Performed Data entry of ICSRs in the safety database, including determining the expectedness of ad-verse events against various labeling documents (such as SPC, CDS, IB, USPC etc.), writing narra-tives, assessing causalities and writing CIOMS comments if required.

Coded complex medical and treatment data reported in clinical trials/Drug Safety to a standard ter-minology in accordance with ICH endorsed guidelines and corporate coding conventions to allow for meaningful evaluation and analysis

Performed Quality review of ICSR including spontaneous and clinical cases.

Performed SAE reconciliation to check the discrepancy between clinical and safety database.

Exercised judgment and use of knowledge of FDA and ICH guidelines and product labeling in per-forming initial case assessment for seriousness, expectedness, causality, listedness and reporting re-quirements.

Reviewed all medical and drug terminologies according to project specific coding conventions, Pack-age Insert, Investigator Brochure and Company Core Data Sheet.

Produced Clinical Safety Queries as needed for clarification of reports. Interacted on a regular basis with Medical monitors, Case Processing Mgrs, and Medical Affairs to

identify process improvement strategies and communicate project status updates.

AE safety profile of assigned drugs, Reference Safety Information documents, data entry conventions and guidelines, clients’ procedures and international drug safety regulations including -ICH guide-lines on safety and efficacy - New PV legislation, Volume 9A –FDA guidelines, CIOMS, US Code of Federal Regulations.

Proficient in of global safety databases like ARGUS, ARISg Expertise in Microsoft Word, Excel, PowerPoint, Project and Outlook.

Therapeutic areas worked – Oncology, Immunology, Cardiovascular & metabolism and Infec-tious diseases.

EDUCATION:

Bachelors in NursingJMJ College of Nursing, Dr. NTR University of Health Sciences, India

Certifications and Licenses:

Registered Nurse - New York State Board of Nursing

Licenses in India, AP Nursing Council Nurse Midwife Public Health Nurse

PROFESSIONAL EXPERIENCE:Pharmacovigilance scientist Sept 2014 – PresentEisai Inc., Woodcliff Lake, NJ

Participated in preparation of Periodic and aggregate safety reports. Author/co-author, along with Global Medical Safety Physicians, regulatory periodic safety reports (Peri-

odic Safety Update Reports, US Periodic Reports): collecting, organizing, analyzing and presenting the data by means of DS&E templates and procedures. 

Review global marketing programs and establish process for AEs collection with global marketing teams.  Alert the Medical Safety Physicians of potential safety issues and assisted the Medical Safety Physicians

in monitoring the safety profile of products. Performed aggregate safety analysis and case level review in Infectious Diseases, Vaccines Prepared and coordinated reviews of individual case safety reports as well as aggregate safety data Interpreted, analyzed, and clearly presented scientific and technical data in verbal and written format Participated in analysis and design process, data listings, clinical data presentation plan review, and clini-

cal study report Ensured timely, quality reports/safety analyses related to core deliverables Performed quality review of individual case safety reports and for providing feedback to team members,

working closely with the Case Processing team and Medical Reviewers to ensure complete and accurate information has been entered into the safety database.

Supported Risk Management Plans by serving as a coordinator for data acquisition and preparation for review from multiple sources

Supported Physicians, in roles such as case series review, data review, draft reports Assisted in organizing or running searches of safety or regulatory databases Collaborated with Electronic Data Management team to reconcile Serious Adverse Events between the

Clinical and Safety databases to meet joint accountabilities and enable locking of Clinical database. 

Clinical Safety Specialist July 2012 – May 2014Teva Pharmaceuticals, Horsham, PA

Responsibilities: Received documented and processed adverse event (AE) reports from clinical trials and post-market-

ing in accordance with company Standard Operating Procedures (SOPs). Performed initial book-in and assessment of incoming reports from various sources- structured and

unstructured. Performed case Prioritization/Triaging based on seriousness of adverse events in accordance with

SOP guidelines. Identified cases that meet SUSAR reporting criteria, prepared the SUSAR narrative, performed risk

assessment. Identified and evaluated safety signals based on individual cases and cumulative data assessment. Accepted E2B cases received through the Argus Electronic Submissions Module (ESM).  Processed cases with an accuracy and consistency at various stages of the system workflow. Performed manual coding of AEs using MedDRA dictionary for the events that were auto-encoded Prepared narrative summaries for AE reports independently from clinical studies and spontaneous

post-marketing reports. Performed necessary follow-up for missing, discrepant or additional information from source docu-

mentation.  Generated queries using safety database for clarification, resolving and forwarding to next work

flow. Performed regular review of individual subject safety data and cumulative safety data with a

physician consistent with the safety review plan; review clinical data for safety signals; obtain opinion of key opinion leaders relating to safety signals.

Attended Safety Review & Risk Management Committee meetings; present new SAEs and AEs of in-terest.

Written narratives for SAEs and AEs of Interest; also reviewed narratives written by colleagues. Collaborated with Safety Manager and Data Management to reconcile safety and patient databases Served as primary contact with safety group, internal governance, regulatory, project team members

and also external investigators and monitors to provide study level medical and scientific support and resolution of study-related issues.

Drug Safety Associate Jan 2011 – June 2012Aurobindo Pharma USA Inc, Bridgewater, NJResponsibilities: Handed safety issues from clinical studies simultaneously by managing all the SAEs from initial re-

porting till case closure. Attended team management meetings on daily workload distribution and ensure timely delivery of

sponsor requirements by prioritization and resource management within team. Worked in Book-in, triaging, data entry, processing, QC, reconciliation and with case closure

team as well. Managed SAEs and Product Issues (complaints) data occurring in clinical studies. Written narratives on SAEs, AEs, and events of special interest in clinical studies on antipsychotic

medication. Written patient narratives with data taken from multiple sources for studies involving cross-functional

collaboration with Study Delivery, Patient Safety, Statistical Programming, and Regulatory to support requests from the FDA.

Performed safety related investigation into the extent of an expired medication problem and related SAEs.

Reviewed case report forms, informed consent forms from investigator sites, reports from clinical re-search organizations.

Given special responsibilities to handle highly important cases which are SUSAR’s and FATAL/LIFE THREATENING and needs expedited reporting within few hours.

Worked in overdose cases and handled these specialty cases carefully along with creating and dis-tributing overdose notifications for all the Principle Investigators around the world ASAP.

Handled and reviewing relevant safety tracking system for accuracy and quality. Coding adverse events and medications with help of latest coding standards in MedDRA. Written narratives on each safety report processed. Processed each and every case individually, by assessing the safety issues and prioritizing them ac-

cordingly before submitting them to the FDA. Created Urgent Safety queries and safety queries in INFORM and communicating with the sites all

over the world over phone and through e-mail in order to process safety issues as required. Experienced in handling paper files as well as electronic files.

Krishna Institute of Medical Sciences, Hyderabad, India Feb 2010 – Oct 2010Kidney Transplant Unit: Staff Nurse Responsibilities: Took care of patients with Isolation, End Stage Renal Disease, Peritoneal Dialysis, Hemo Dialysis,

Post Renal Transplant care, acute rejection. Organized patient care in Kidney transplant unit. Ensured the working efficiency of the Unit. Conducted physical assessments on patients. Developed nursing care plans. Took care of the Patients on dialysis, monitored strict intake output chart as per doctors’ orders,

cardiac monitoring and interpretation, frequent monitoring of vital signs, frequent nursing and ancillary interventions, catheter care, and management and retrieval of laboratory results

Educated Patients on post-transplant care and rejection prevention. Maintained records and reports of the patients.

JMJ College of Nursing, Hyderabad, India March 2009 - February 2010Nursing Faculty-Clinical InstructorResponsibilities: Demonstrated patient care in classroom and clinical units to nursing students and instructs students

in principles and application of physical, biological, and psychological subjects related to nursing. Lectured to students, conducted and supervised laboratory work, issued assignments, and directed

seminars and panels. Supervised student nurses and demonstrated patient care in clinical units of hospital. Prepared and administered examinations, evaluated student progress, and maintained records of stu-

dent classroom and clinical experience. Participated in planning curriculum, teaching schedule, and course outline as per Indian Nursing

Council. Coordinated with medical and nursing personnel in evaluating and improving teaching and nursing

practices.