Summary
Overview
Work History
Education
Skills
Accomplishments
Tel
References
Training
Poetry, Travelling, Sketching
Timeline
Generic
NIDHI GAUTAM

NIDHI GAUTAM

Drug Safety Professional

Summary

Seasoned Drug Safety and Pharmacovigilance Professional always putting patient safety first. Knowledgeable about all areas of Drug Safety, Pharmacovigilance and regulatory. Offering overall more than 11 years of experience in industry. Also a pharmacist by degree with strong and versatile experience ranging from ICSRs to aggregate reports in various therapeutic areas including Vaccine and Immunology, Oncology, Cardiovascular, Pain and Allergy & CNS.

Efficient writing in safety reports including responding to Regulatory requests, drug renewals, PBRER, DSUR, PADERs, Addendum to clinical overviews, SUSAR summary reports,Signal Evaluation reports reviewing, writing, compiling, supervising, collaborating and publishing. Proficient in safety databases including ARISg, ARGUS.

Well-rounded knowledge of a product life cycle requirement from pre-to post-marketing mainly focusing on the safety profile of the drug.

Ambitious and highly motivated, surpasses demanding objectives and achieves set goals. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Overview

11
11
years of professional experience

Work History

Associate Director, Senior Patient Safety Scientist

ASTRAZENECA
6 2021 - Current
  • Assigned to Covid-19 Vaccine Project and Monoclonal antibodies.
  • Authors/provides strategic input or oversight for the Vaccine Periodic regulatory documents (PBRERs, DSURs, MSSRs and RMP) according to the agreed process and timelines
  • Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA) in partnership with the GSP and other functional experts
  • Signal detection and surveillance.
  • Trains and mentors junior members of the team, e.g
  • In approved PV processes, analytic methodologies
  • Manage and monitor vendors for data retrieval and medical writing
  • Work cross functionally closely with Regulatory Clinical teams
  • Work with multiple time zones (US and Asia).
  • Established strong relationships with key industry partners, creating mutually beneficial opportunities for growth and collaboration.
  • Maintained compliance with industry regulations while adapting to changes in legislation or best practices as needed.

Pharmacovigilance Scientist

KYOWA KIRIN
04.2021 - 05.2021
  • Assigned to different developmental and post marketing products safety profile
  • Authoring and reviewing of PBRER, DSURs, RMPs
  • Signal detection report writing including EVDAS data reviews
  • Manage and monitor vendors for data retrieval and medical writing.

Global Patient Safety Scientist

IPSEN Biopharm
04.2020 - 12.2020
  • Assigned to an oncology development product, responsible for reviewing of the reporting plan, study protocols, clinical safety reports (CSRs), study outputs (TFLs), SAPs for all clinical trials
  • Lead author for indication 5-year and 1-year renewal document to the EMA
  • Working with a partner company to compile and review the PBRER, DSURs, RMPs
  • Signal detection report writing including EVDAS data reviews
  • Manage and monitor vendors for data retrieval and medical writing
  • Work cross functionally closely with Regulatory Clinical teams
  • Work with multiple time zones (US and Asia) Ensure the timely provision of all safety deliverables to enable progress with clinical trials (Interventional and non-interventional), including facilitating the activities of Data Safety Monitoring Committees
  • Support the Pharmacovigilance Physician with ad-hoc activities
  • Prepare power point presentations on safety updates for team & department meetings
  • Liaise with Global Drug Development CROs to ensure that SAE data within the clinical and Global Patient Safety databases are accurately reconciled in a timely manner for all clinical trials Ensure the timely delivery of accurate information, in DSURs, and SUSARs to investigators and Ethics Committees, with the generation of periodic line listings.

Medical Writer

Covance
06.2018 - 11.2019
  • Preparing Periodic Safety Reports (PSRs) including Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs), Addendum to Clinical Overviews (ACOs), Risk Management Plan (RMP), Developmental Safety Update Report (DSUR), Company Core Data Sheet and Adhoc reports
  • Conducting and collating information from various stakeholders for report completeness
  • Performing quality check as per client requirement
  • Delivering PSRs in accordance with the regulatory timelines with 100% compliance
  • Sending queries and liaising with the relevant client personnel regarding discrepancies for obtaining incomplete/missing information with a view to resolve and clarify issues and facilitate processing of the reports
  • Performing quality check of reports written by other authors
  • Actively involved in process improvement and automation for safety writing process for example automation for sending Call for Information
  • Software skills: SAS JMP, MedDRA, MS office
  • Delivering training for new joiners as per requirement.

Senior Research Scientist

Sun Pharma Industries Private Limited
10.2017 - 05.2018
  • Drafting and review of assigned PSURs/PBRERs/ACOs ensuring 100% compliance as per applicable SOP and guidelines regulations
  • Drafting of molecule specific signal evaluation reports
  • Drafting of molecule specific Signal Input Reports for ACOs/PBRERs/PSURs and safety evaluation reports
  • Quality review of the data presents in signal evaluation reports
  • Quality review of the data presents Signal Input Reports for ACOs/PBRERs/PSURs and safety evaluation reports
  • Processing of Signals of Disproportionate reporting (SDRs)
  • Assisting in evaluation of case occurrences
  • Assisting in causality assessment of unexpected case occurrences/SDRs
  • Maintaining and updating signal tracking sheets and other signal management trackers as allocated
  • Soft and hard copy archival of documents related to safety signal management activities
  • Working with ARGUS database.

Pharmacovigilance Scientist

PAREXEL International
04.2015 - 10.2017
  • Preparing PSRs including PBRERs, ACOs and Semi-Annual Safety Reports (SASRs) in accordance with client requirements/conventions and Standard Operating Procedures (SOPs)
  • Experienced in MedDRA coding in accordance with “MedDRA Term selection: Points to consider”
  • Working knowledge of the AE safety profile of assigned drugs/class of drugs, Reference Safety Information documents, data entry conventions and guideline, clients' procedures and international drug safety regulations including: ICH guidelines on safety and efficacy, Volume 9A, FDA guidelines, CIOMS and New EU PV legislation
  • Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
  • Experienced in handling the ERP systems (Enterprise Resource Planning)
  • Preparing of PADERs
  • Worked with AWARE, DOMASYS database
  • Efficient in MedDRA.

Lecturer

Department of Pharmacy, Barkatullah University
03.2013 - 01.2015
  • Engaged in theory and practical sessions for B Pharm and M Pharm batches.

Education

Master of Pharmacy in Pharmaceutics -

Department of Pharmacy Barkatullah University
07.2010 - 2012.05

Bachelor of Pharmacy (Hons) -

Department of Pharmacy Barkatullah University
07.2006 - 2010.05

Skills

Team Collaboration and Leadership

Strategic leadership

Decision-Making

Organizational Development

Analytical Thinking

Coaching and Mentoring

Onboarding and training

Professional Networking

Database Management

Process Improvement

Regulatory Compliance

Accomplishments

  • Poster presented Entitled Hepatotoxicity of Anti diabetic Drugs at National level Paper Contest in NRI College of pharmacy Bhopal on 11 and 12 November 2008. (1st prize).
  • Oral Paper presented Entitled Autism: Condition or a Disorder at National level Paper Contest in NRI College of Pharmacy Bhopal on 11 and 12 November 2008. (1st Prize).
  • Participated in various debate and group discussion competitions at school and college level.
  • Participated in various sports and cultural events at school and college level.
  • Class representative in B. Pharm. & M. Pharm.

Tel

07459 118686

References

available on request.

Training

  • Participated in 13th National Convention of Society of Pharmacognosy held in Department of Pharmacy, Barkatullah University, Bhopal (M.P.) on 15th and 16th February 2009.
  • Participated in National Seminar on Emerging Approaches in phytotherapy and Cancer Research on 2 April 2009.
  • Participated in National Seminar on Current Scenario of Pharmacy Practice and Education. (Sponsored by AICTE in IES College of Pharmacy, Bhopal)

Poetry, Travelling, Sketching

love to write and draw what I feel while travelling.

Published my own book entitled "Inkedbysoul Part 1"

Timeline

Pharmacovigilance Scientist

KYOWA KIRIN
04.2021 - 05.2021

Global Patient Safety Scientist

IPSEN Biopharm
04.2020 - 12.2020

Medical Writer

Covance
06.2018 - 11.2019

Senior Research Scientist

Sun Pharma Industries Private Limited
10.2017 - 05.2018

Pharmacovigilance Scientist

PAREXEL International
04.2015 - 10.2017

Lecturer

Department of Pharmacy, Barkatullah University
03.2013 - 01.2015

Master of Pharmacy in Pharmaceutics -

Department of Pharmacy Barkatullah University
07.2010 - 2012.05

Bachelor of Pharmacy (Hons) -

Department of Pharmacy Barkatullah University
07.2006 - 2010.05

Associate Director, Senior Patient Safety Scientist

ASTRAZENECA
6 2021 - Current

Similar Profiles

CREATE PROFILE
NIDHI GAUTAMDrug Safety Professional