Priyanka Thakur is a registered nurse with 8 years of experience, including 5+ years in pharmacovigilance. She has expertise in adverse event processing and reporting, preparing periodic safety reports, triaging adverse event reports, and ensuring consistency in safety event assessment and reporting. She is proficient in global safety databases and Microsoft Office applications.

1. 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),
Medical 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
concerns.
 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
adverse events against various labeling documents (such as SPC, CDS, IB, USPC etc.), writing
narratives, assessing causalities and writing CIOMS comments if required.
 Coded complex medical and treatment data reported in clinical trials/Drug Safety to a standard
terminology 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
performing initial case assessment for seriousness, expectedness, causality, listedness and reporting
requirements.
 Reviewed all medical and drug terminologies according to project specific coding conventions,
Package 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 guidelines 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
Infectious diseases.

2. EDUCATION:
Bachelors in Nursing
JMJ 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 – Present
Eisai 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
(Periodic 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
clinical 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 2014
Teva Pharmaceuticals, Horsham, PA
Responsibilities:
 Received documented and processed adverse event (AE) reports from clinical trials and post-
marketing in accordance with company Standard Operating Procedures (SOPs).

3.  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
documentation.
 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
interest.
 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 2012
Aurobindo Pharma USA Inc, Bridgewater, NJ
Responsibilities:
 Handed safety issues from clinical studies simultaneously by managing all the SAEs from initial
reporting 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
research organizations.
 Given special responsibilities to handle highly important cases which are SUSAR’s and
FATAL/LIFE THREATENING and needs expedited reporting within few hours.

4.  Worked in overdose cases and handled these specialty cases carefully along with creating and
distributing 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
accordingly 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 2010
Kidney 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 2010
Nursing Faculty-Clinical Instructor
Responsibilities:
 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
student 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.