Summary
Overview
Work History
Education
Skills
Accomplishments
Personal Information
Timeline
Generic
Hita John

Hita John

Bad Homburg

Summary

Experienced healthcare professional with 9+ years of expertise in pharmaceutical and healthcare industry. Skilled in Quality, Pharmacovigilance, Regulatory Affairs, Market Research, Patient Support Programs, Real World Evidence, and Business Development. Extensive experience collaborating with senior-level professionals and competent authorities in the pharmaceutical industry. Strong academic background in Clinical Research with an Advanced Professional Diploma in Clinical Research and Pharmacovigilance from Clinotek, Centre of Clinical Research Studies, Bangalore. Also holds an MBA in Health and Safety from Venkateshwara University, India, and is a Registered Dentist with a Bachelor of Dental Surgery (BDS) from Rajiv Gandhi University of Health Sciences. Certified at C1 level for German language proficiency from Goethe Institute, Frankfurt, and achieved an IELTS Band 8 in English language proficiency. Exceptional communication skills, efficient time management abilities, quick learner, and attentive listener. Adaptable to new situations with a positive mindset. Detail-oriented and hardworking.

Overview

10
10
years of professional experience

Work History

Sr. Associate, Medicines Quality

Lilly Deutschland GmbH
08.2019 - Current
  • Pharmacovigilance System Master File (PSMF) review and maintenance to ensure that it is always in a state of Inspection readiness
  • Medicines Quality consultant in Pharmacovigilance and Regulatory affairs for the German hub (includes Germany, Austria and Switzerland)
  • Conducting Self-inspections as Lead Inspector and preparing and working with the affiliate for GQAAC Audits internally, as well as provide support to the affiliate during the preparation and execution of external Regulatory inspections
  • Worked with several cross-functional teams including Patient Support Program teams, Market research, Real World evidence and often provided Quality consultation to these teams -Experienced in writing Deviations, change controls and Root Cause Investigations (RCI)
  • Presented and provided knowledge sharing sessions during several internal meetings. -Worked with several databases including Argus safety, Trackwise, Regulatory Information Management (RIM), Veeva Vault, Power BI, Sharepoint
  • Currently Subject Matter Expert (SME) within MQO for the following areas: PSMF, RIM, Market research, Third party management and Root cause Investigations (RCI)s
  • Recipient of the Quality Pinnacle award 2022 for having identified Regulatory knowledge gaps across the EU Affiliates and created and implemented training materials and an onboarding package to close the knowledge gap for EU Regulatory affiliates and International Medicines Quality Consultants.

Section Head- Regulatory affairs and Pharmacovigilance

SGS Gulf Limited
02.2017 - 02.2019
  • Complete management and handling of all regulatory affairs and pharmaceutical activities of the company
  • Consultation services, business development and subject matter expert in Regulatory affairs and Pharmacovigilance
  • Reporting of spontaneous ICSRs to Suppliers and Health authority
  • Tracking of ICSRs and perform ICSR reconciliation with Business partners if required
  • Collecting all the data of ADRs to fill the CIOMS form. Fill CIOMS form and send them to Principal companies and relevant authorities
  • Prepare and review SOPs, SDEA
  • Assisting with pharmacovigilance processes, supporting preparation of SOP's, product safety review and literature review
  • Literature screening and finding relevant articles related to the suppliers and creating an ICSR for it. Participate in preparation of inspection and audits
  • Ensuring of compliance in Pharmacovigilance and Regulatory activities
  • Consultation services for Classification of Drugs and Registration of Drugs with the Ministry of Health
  • Inspected Pharmaceutical warehouse for Good storage (GSP) and Good distribution Practices (GDP)
  • Registration and Certification of products for Emirates Authority for Standardization and Metrology (ESMA) checking for compliance as per Gulf Standards.

Associate Operations Specialist

IQVIA
07.2014 - 07.2016
  • Triaging, Case processing and Narrative writing for Clinical trials and post marketing drugs. Receive, triage, review and process data from various sources on time, within budget and meet quality standards
  • Perform data entry for tracking and safety database, coding relevant medical terminology, writing descript narratives, generating queries pertinent to the case, performing quality control, assisting with reconciliation, coordinating translations and ensuring reports are sent to the customer within assigned deadlines. Receive and document incoming faxes and emails from investigative sites or other sources reporting safety data. Responsibility of the global intake which included direct communications and email communications with the client, responding to client queries and raising general queries of the team to the client. Process safety data according to applicable regulations, guidelines, standard operating procedures and project requirements.

Education

Bachelor of Dental Surgery (BDS) -

Rajiv Gandhi Dental College
01.2012

Master of Business Administration (MBA) -

Venkateshwara Open University
01.2019

Advanced professional Diploma in Clinical Research and Pharmacovigilance -

Clinotek
01.2014

Band 8 in English -

IELTS, Dubai

Certified in C1 in German language -

Goethe Institute, Frankfurt

Skills

  • Pharmacovigilance System Master file-review, maintenance and Quality Check
  • Sound knowledge on Periodic metrics and additional Risk Minimization metrics-review and Quality check
  • Change control, Deviation and Root Cause Investigation writing
  • Support in Audits and Inspections
  • Experienced working with cross-functional teams including Patient support program teams, Market research, RWE and Third party management teams
  • Reviewed and updated Procedures, Required tools and Resource documents in Veeva Vault Quality Docs

Accomplishments

Recipient of the Quality Pinnacle award 2022 for having identified Regulatory knowledge gaps across the EU Affiliates and created and implemented training materials and an onboarding package to close the knowledge gap for EU Regulatory affiliates and International Medicines Quality Consultants.

Personal Information

Title: Senior Associate - Medicines Quality

Timeline

Sr. Associate, Medicines Quality

Lilly Deutschland GmbH
08.2019 - Current

Section Head- Regulatory affairs and Pharmacovigilance

SGS Gulf Limited
02.2017 - 02.2019

Associate Operations Specialist

IQVIA
07.2014 - 07.2016

Bachelor of Dental Surgery (BDS) -

Rajiv Gandhi Dental College

Master of Business Administration (MBA) -

Venkateshwara Open University

Advanced professional Diploma in Clinical Research and Pharmacovigilance -

Clinotek

Band 8 in English -

IELTS, Dubai

Certified in C1 in German language -

Goethe Institute, Frankfurt

Similar Profiles

CREATE PROFILE
Hita John