Summary
Overview
Work History
Education
Skills
Personal Profile
Hobbies and Interests
Timeline
Generic

Annie Anto

Bangalore

Summary

Experienced Pharma Industry professional with 13+ years of experience specializing in triaging safety information and ensuring regulatory compliance. Skilled Deviation Expert with a strong background in supporting audits and inspections in Safety and Compliance. Proficient in global drug safety databases like Argus. Experienced in conducting trainings, handling reconciliation for Non-interventional studies, managing projects for over 2 years, and writing Non-conformities/Deviations for over 4 years. Expertise in Stakeholder Management for over 6 years.

Overview

15
15
years of professional experience

Work History

Associate Manager

Novo Nordisk Service Centre (India) Pvt. Ltd
11.2024 - Current
  • Conduct 3P, individual development plans, job descriptions and performance evaluation.
  • Ensure continuous development of employees, training/coaching in pharmacovigilance and in departmental functions as well as provision of knowledge about NN business.
  • Participate in the development of procedures for clinical development in Novo Nordisk, which will ensure the observance of both internal as well as external requirements concerning the management of safety information.
  • Ensure accurate and consistent coding using MedDRA of all adverse events reported to NN to ensure consistency and precision between projects, products and countries in the coding of adverse events for Novo Nordisk products.
  • To negotiate processes for collaboration with Contract Research Organisations regarding SAE reporting and establish excellent working relationships with these.
  • To participate in the development and maintenance of departmental and functional procedures which have to ensure the observance of internal and external requirements for the management of safety information
  • Department: Global Safety, Bangalore
  • Tenure: 01-Nov-2024 to till date

Team Lead

Novo Nordisk Service Centre (India) Pvt. Ltd
02.2022 - 11.2024
  • Conduct 3P, individual development plans, job descriptions and performance evaluation.
  • Ensure continuous development of employees, training/coaching in pharmacovigilance and in departmental functions as well as provision of knowledge about NN business.
  • Participate in the development of procedures for clinical development in Novo Nordisk, which will ensure the observance of both internal as well as external requirements concerning the management of safety information.
  • Ensure accurate and consistent coding using MedDRA of all adverse events reported to NN to ensure consistency and precision between projects, products and countries in the coding of adverse events for Novo Nordisk products.
  • To negotiate processes for collaboration with Contract Research Organisations regarding SAE reporting and establish excellent working relationships with these.
  • To participate in the development and maintenance of departmental and functional procedures which have to ensure the observance of internal and external requirements for the management of safety information
  • Department: Global Safety, Bangalore
  • Tenure: 01-Feb-2022 to 01-Nov-2024

Regulatory Professional I

Novo Nordisk Service Centre (India) Pvt. Ltd
12.2020 - 02.2023
  • Support and provide input to all regulatory submissions to Health Authorities worldwide
  • Support and provide input to regulatory interactions with Health Authorities
  • Establish and maintain core labelling
  • Support and drive process development and optimisation
  • Keeping up to date on regulatory knowledge and sharing better practise
  • Responsible for updating or maintain regulatory files within the defined area of responsibility, including evaluation of the regulatory implications of changes and necessary actions
  • Maintain life cycle management (LCM)activities of Norditropin
  • Core labelling approver(case handler from HQ for Biopharm portfolio
  • Department: GRA Bangalore
  • Tenure: 01-Dec-2020 -01-Feb-2023

Regulatory Professional II

Novo Nordisk Service Centre (India) Pvt. Ltd
05.2019 - 12.2020
  • Responsible for planning, coordination and executing the clinical regulatory tasks as required in the projects or existing products in accordance with the regulatory strategy for the defined area of responsibility
  • Responsible for preparation and compilation of the individual sections of all files for the defined area of responsibility, in accordance with internal requirements and external regulatory guidelines and regulations
  • Facilitates approval of all files for the defined area of responsibility
  • Responsible for the regulatory interaction concerning scientific issues with stakeholders, affiliates and authorities for all files within the defined area of responsibility
  • Responsible for updating or maintain regulatory files within the defined area of responsibility, including evaluation of the regulatory implications of changes and necessary actions
  • Ensuring regulatory compliance with the legislation on pharmacovigilance for the defined products
  • Department: GRA Bangalore
  • Tenure: 02-MAY-2019 to 01-Dec-2020

Business Analyst I – IT-Compliance

Novo Nordisk Service Centre (India) Pvt. Ltd
01.2017 - 05.2019
  • Perform compliance related tasks provided as services from the department for authoring IT compliance documentation
  • Facilitate CAPA service: Create nonconformity Draft for different stake holders, help stake holders for 5X why analysis, fish bone analysis, help to find out the corrective actions.
  • Develop plans, execute and deliver the services with acceptable service evaluations.
  • Perform stakeholder management and collaborate as a part of delivering services involving multiple stakeholders from CMC and product supply and Global Safety and IT departments with diverse interests, knowledge, cultural background and personality.
  • C-Lean 1 Star holder for process optimization in Europe region
  • Department: ITSS Compliance Services II
  • Tenure: 09-JAN-2017 -02-May-2019

Drug Safety Associate - II

Novo Nordisk Service Centre (India) Pvt. Ltd
11.2013 - 01.2017
  • To database the safety information in Argus
  • Triage of safety information received via various sources.
  • To process serious and non-serious cases.
  • Handling of Non-conformities and remarks as NC owner for the department
  • Create Change request
  • Handling of reconciliation
  • Handling of PSUR clean up
  • To perform case allocation
  • To capture the safety information in Argus accurately, assess company causality, writing perfect case narrative and sending required follow-up questions.
  • To ensure accurate and consistent coding of all events with the use of MedDRA(medical dictionary of regulatory activities)
  • To check for the completeness of the safety information received in case and queries the sender or affiliate as required.
  • Department: Global Safety (GS-GSC)
  • Tenure: 03-Nov-2013 till 09-JAN-2017

Junior Drug Safety Associate

Novo Nordisk Service Centre (India) Pvt. Ltd
01.2012 - 01.2014
  • To database the safety information in Argus
  • To process non-serious cases.
  • To handle PSUR clean ups.
  • To capture the safety information in Argus accurately, assess company causality, writing perfect case narrative and sending required follow-up questions.
  • To check for the completeness of the safety information received in case and query the sender or affiliate as required.
  • Department: Global Safety (GS-GSC)
  • Tenure: 02-JAN-2012-01-JAN-2014

Intern

Novo Nordisk India Pvt. Ltd
07.2012 - 09.2012
  • To ensure clinical trial documentation was performed to submit to Health authorities.
  • To ensure that informed consent was as per ICH-GCP guideline
  • To co-ordinate with the site the trial related activities.
  • To collect and coordinate the review of ICH-translation in different languages.
  • Achieving the trial related documents in a systematic manner.
  • Department: Department of clinical and regulatory and medical affairs
  • Tenure: 04-JUL-2012 to 30-SEP-2012

Clinical Research Associate Trainee

Bangalore Diabetes Center
01.2011 - 03.2011
  • To ensure procedure are in place for appropriate optimization of patients into clinical trial
  • Coordinate the movement of laboratory samples and results
  • To update patient information in EDC
  • Be the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing trials.
  • Department: Clinical research
  • Tenure: 01-JAN-2011 to 30-MAR-2011

Education

Master of Science - Molecular Biotechnology

University of Bonn
09.2009

Bachelor of Science - Biotechnology

St. Joseph College, University of Calicut
01.2004

Skills

  • Strategic planning expertise
  • Effective verbal and written communication
  • Self-directed work
  • Effective stakeholder engagement
  • Effective presentation skills
  • Proficient in Microsoft Office suite
  • Skilled in Excel and Word applications

Personal Profile

Languages Known: English, Hindi, Malayalam, German (Level A2)

Hobbies and Interests

Chess, Badminton and Music

Timeline

Associate Manager

Novo Nordisk Service Centre (India) Pvt. Ltd
11.2024 - Current

Team Lead

Novo Nordisk Service Centre (India) Pvt. Ltd
02.2022 - 11.2024

Regulatory Professional I

Novo Nordisk Service Centre (India) Pvt. Ltd
12.2020 - 02.2023

Regulatory Professional II

Novo Nordisk Service Centre (India) Pvt. Ltd
05.2019 - 12.2020

Business Analyst I – IT-Compliance

Novo Nordisk Service Centre (India) Pvt. Ltd
01.2017 - 05.2019

Drug Safety Associate - II

Novo Nordisk Service Centre (India) Pvt. Ltd
11.2013 - 01.2017

Intern

Novo Nordisk India Pvt. Ltd
07.2012 - 09.2012

Junior Drug Safety Associate

Novo Nordisk Service Centre (India) Pvt. Ltd
01.2012 - 01.2014

Clinical Research Associate Trainee

Bangalore Diabetes Center
01.2011 - 03.2011

Bachelor of Science - Biotechnology

St. Joseph College, University of Calicut

Master of Science - Molecular Biotechnology

University of Bonn
Annie Anto