Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Affiliations
Certification
References
Timeline
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Sharon Vidya Sagar

Sharon Vidya Sagar

Vaughan,Canada

Summary

Safety-conscious and adaptable professional with a strong work ethic and a passion for continuous learning. Proven track record of delivering high-quality results and fostering strong relationships with stakeholders. Recognized for excellent communication and problem-solving abilities. Eager to contribute to a dynamic team by leveraging specialized skills in drug safety guidelines, scientific literature, regulatory writing, and medical communication. Committed to achieving company goals and delivering exceptional service, with strengths in time management, critical thinking, and collaboration to ensure successful project delivery under tight deadlines.

Overview

8
8
years of professional experience
1
1
Certification

Work History

Associate Safety Medical Writer

Novo Nordisk Service Center Pvt Ltd
Bangalore
06.2021 - 08.2024
  • (Diabetes, Obesity, Hemophilia, Hormone replacement therapy), Safety Surveillance, GS-GBS
  • Planned, driven, and coordinated preparation of regulatory safety documents (PSUR, DSUR and ACO) to ensure submission according to agreed timelines
  • Prepared replies to authorities in relation to assessment reports when applicable
  • Performed consistency review of documents (QC, formatting, and language check) as back- up SMW for reports
  • Participated in relevant internal/external medical activities, e.g., trainings and conferences
  • Ensured that documents are in accordance with SOPs and external guidelines
  • Contributed to knowledge sharing, skill building and good collaboration with global stakeholders and colleagues
  • Proficient in using data analytical tool, in workflow management and collaborative review & co-authoring applications (Veeva Vault)
  • Acted as a mentor for colleagues and conduct trainings, knowledge sharing sessions as required
  • Key Responsibilities:

Drug Safety Associate I & II

Bangalore
12.2016 - 06.2021
  • Safety operations, GS- GBS
  • Expertise in triage, processing (data entry and verification) of serious and non-serious individual case safety reports (ICSRs) from post-marketing studies (PMS), literature, digital health, health authority and spontaneous case reports, with emphasis on accuracy, timeliness, and quality of safety data
  • Assessed adverse event reports for seriousness, causality and expectedness and evaluate serious adverse event reports to ensure accurate and consistent data entry and processing from source documents, with emphasis on timelines and high quality
  • Diligent work allocation for case processing via MS Excel and/or Argus database and never missed the regulatory timelines
  • Skilled in coding of various medical conditions to the exact match using the Medical Dictionary for Regulatory Activities (MedDRA)
  • Represented safety operations in the monthly case handling meetings for 2 years with specialists and experts and thus helped to disseminate new information in the department meetings
  • Act as subject matter expert (SME)/ go-to person for case handling queries and various safety processes (Device cases, Eudravigilance cases and Literature Surveillance)
  • Performed literature surveillance activities by reviewing the medical journals/articles to identify ICSRs according to appropriate regulations and standard processes
  • Participated as one of POCs for 'Audits and inspections for device case processing, Eudravigilance cases and affiliate support activities when required
  • Active involvement in pre- inspection and post-inspection review and clean-up projects
  • Meticulously handled the international mailbox for post-marketing cases, ensuring timely and accurate handling of health authority request, affiliate inquiries and case reports
  • Responsible for updating the Non-serious case Line Listing (NSLL) with appropriate root cause analysis (RCA) of missed KPI cases or late submission cases
  • Act as 'SOSPON Mailbox sponsor' for a year and was responsible for delegating access and training of new mailbox responsible personnel
  • Handled review of source documents (Customer complaint form, CCF) received through mail to book-in cases in CCGloW
  • Ensured CCF redaction and CCF verification along with data reconciliations with affiliate
  • Argus triage of the booked-in cases
  • Maintained good stakeholder relations with affiliates and addressed their queries with due diligence
  • Accountable for generating appropriate queries and requests for clarification and/or follow up information to ensure accurate and complete patient information was present
  • Ad hoc meetings with affiliates to clarify and confirm processes for country specific conventions
  • Buddy for 5 new joiners to process cases independently
  • Train new team members on EUMDR device case handling along with Device advisor and expert, EDC-Inform cases, and affiliate support activities
  • Key Responsibilities:
  • Case processing:
  • Mailbox handler
  • Affiliate support activity
  • Training and buddy

Project manager-SRR

Bangalore
09.2020 - 12.2020
  • Scientific Recruitment and Retention (SRR) Team, Global Medical Affairs
  • Created SRR Material i.e
  • A screening card for Investigators
  • Developed SRR Library on SharePoint and proposed Guidance for uploading SRR Materials into it which included setting attributes for Global and local meeting materials, and patient material of the completed outcome trials
  • Attended Project Forum and National study coordinator meeting of an ongoing trial
  • Attended trainings and gained knowledge about SRR tools, HCP management process, vendor management, budget and contract preparations
  • Short Time Assignment:
  • Duration: 4 months
  • Department:
  • Key Responsibilities:

Education

Doctor of Pharmacy - PharmD

St. Peter's Institute of Pharmaceutical Sciences
Telangana, India
11-2016

Skills

  • Veeva Vault
  • Qlik Sense
  • SharePoint
  • PleaseReview
  • Oracle Argus
  • NovoGlow
  • Oracle InForm EDC
  • MedDRA
  • Eudravigilance
  • MS Word, Excel, Project and Powerpoint
  • Adobe Acrobat DC

Accomplishments

  • Honored with 'Exceeds expectations', for being highly productive and with exceptional quality in annual performance review of 2019.
  • Nominated for 'NN Way Champion award' for going above and beyond GS strategy and essential 7 in 2020.
  • Privileged to be part of 'Next 10' development initiative and travelled to Denmark for interactions with specialist and QPPV. Created a process flow chart on 'Patient Safety Surveillance' and presented on the topic 'Literature Surveillance' to the process experts.
  • Part of 'PV Academy' working group 2020, prepared PV booklet for internal use. Facilitated the workshop and completed it with good remarks.
  • Worked in 'Simplification of Allocation Process (SAP)' Project.
  • Attended DIA India PV conference from Novo Nordisk.
  • Second prize winner of Fit4Take-off Moon walk-GBS.
  • Awarded with 'Going Extra Mile-GEM award' for Q3 of 2023.
  • Conducted workshops as an active member of 'Spark It up and innovation' working group 2023.
  • Conducted workshops on 'Work-Life Balance' 2023.
  • Organised team building activities for the department area.
  • Served as an anchor for few corporate events in GS.
  • As part of GS-GBS Offsite 2023 working group, organised, and hosted 3-day offsite for Global safety.
  • Actively participated and contributed in numerous NN initiatives such as Leap, Fun/FEST group... etc...and cultural programs.

Languages

English
Native/ Bilingual
Hindi
Native/ Bilingual
Telugu
Native/ Bilingual
French
Elementary

Affiliations

o Amateur color pencil sketching

o Gardening and landscaping

o Cooking and/or baking

Certification

  • Published a research article in International Journal of Pharmaceutical sciences and Nanotechnology (IJPSN), entitled ‘Determining the efficacy and safety of Duloxetine and Gabapentin in pain reduction on Knee Osteoarthritis patients- An observational study’. ISSN: 6154-6160.
  • Published a research article in Asian Journal of Pharmaceutical and Clinical research, entitled ‘Assessment of awareness of diabetic retinopathy among patients with diabetes mellitus attending the care diabetes center’.

References

References available upon request.

Timeline

Associate Safety Medical Writer

Novo Nordisk Service Center Pvt Ltd
06.2021 - 08.2024

Project manager-SRR

09.2020 - 12.2020

Drug Safety Associate I & II

12.2016 - 06.2021

Doctor of Pharmacy - PharmD

St. Peter's Institute of Pharmaceutical Sciences
Sharon Vidya Sagar