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Candidate Details

Name :

Dennis Galindez
Qualification :
Medical Safety Advisor
Industry :
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Candidate ID:
This candidate has been hired.

Medical Safety Advisor

About our Client

Healthcare professional experienced in working with research organisations, providing scientific insights and solutions to the pharmaceutical industry. Skilled in conducting quality reviews, medical writing/editing, research and project management. Detail-minded with a strong scientific background and thorough knowledge of regulatory environments and clinical drug development. Team player who values collaboration in achieving project goals, as well as ability to work independently.


Professional Experience

Medical Safety Advisor

Overview: Performed medical reviews and clarification of post-marketing Adverse Drug Reactions involving the Moderna mRNA-1273 COVID-19 vaccine

  • Reviewed Adverse Event (AE) coding, Seriousness assessment, Causality assessment, Expectedness assessment, narrative content, queries, and company summary
  • Provided coding review of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), Past Medical History, concomitant medications, and other medical data listings to verify and medically vetted clinical data
  • Served as an internal consultant to Case Processing teams on the Moderna mRNA-1273 vaccine project; ensured service delivery from productivity, compliance, and quality perspective within regulatory and contracted timelines
  • Participated in the initiatives taken from a team delivery perspective; and provided Therapeutic area/PV issue guidance in the context of leading other safety team members in Individual Case Safety Report (ICSR) assessment and processing

Operations Manager

Overview: Led a team on the successful delivery of various projects

  • Achieved 85% delivery of Sales Orders acquired for 2020 over the period of January 2020 to June 2020
  • In collaboration with the Human Resource (HR) Executive, aligned the job descriptions of the Delivery team which ensured that roles were clearly defined and the project process flow was carried out effectively and efficiently
  • Restructured the Project Status tracker and delivery team To-do list tracker to track progress
  • Evaluated the signed Sales Orders for keying in the Sales Management system: identified the project’s required outputs, project tagging, and splitting of revenue between organisation and Marketing Platform,
  • Prepared timelines for signed projects and endorsed all information required for project delivery
  • Led relevant internal team meetings and external stakeholder meetings and answered queries from the Business team, Delivery team and regional teams
  • Addressed project issues and managed escalations to relevant stakeholders
  • Evaluated the cost effectiveness of external suppliers required for project implementation
  • Managed the pool of freelance Medical Writers, Graphic Artists and Video Editors: accomplished consultancy agreement contracts, briefed freelance contributors and managed the quality delivery of assigned projects
  • Conducted technical training sessions for the Project Management team; and evaluated the job performance of the Delivery team and assisted in setting work priorities and goals using the company’s performance management system

Editorial Manager

Overview: Oversaw all aspects of content for publication (print), digital projects, Continuing Medical Education (CME) events, and implementation of Continuing Professional Development (CPD) programs

  • Wrote, edited texts and served as a resource on medical and oversaw all aspects of content for publication (print), digital projects and CME events, and served as a resource on medical and scientific content in the process of project development and new business pitches
  • Conducted research on various therapeutic areas and reviewed the content outline prepared by the Medical Writer based on the project brief; edited and proofread texts and layouts, and ensured adherence to the MIMS MedComms Style Guide (based on the AMA Manual of Style)
  • Ensured that the editorial content adhered to the MIMS standard and relevant guidelines;
  • Supervised and allocated the projects and tasks to the Medical Writers and other contributors; mentored and guided the Medical Writers on how to write for different audience and project types
  • Provided technical training sessions to new and existing personnel, evaluated performance of the Editorial team and assisted in setting work priorities and goals using the company’s performance management system
  • Contributed to the growth of the MedComms division which resulted in 105% delivery of acquired Sales Orders in 2019 and led the discussion and revision of the MedComms SOPs during the Strategic Planning for 2020


Doctor of Medicine

Bachelor of Science (Biology)



Technical Skills

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