Queenita Fernandes work email
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- Expertise in Medical Device Industry: Post Market Complaint Handling, FDA Reporting & Submissions related to device malfunctions and adverse event reporting - Expertise in Medical & Regulatory Writing [Clinical Evaluation Reports (CERs), Clinical Report Forms (CRFs), Clinical Study Reports (CSRs), Investigatory Brochures (IBs) etc.]- Expertise in Biomed & Life Sciences Research & Writing [Competitive Intelligent Reports, Clinicaltrials.gov, PubMed / MAUDE database research]- Expertise in Pharmaceutical Publications Writing [Marketing proposal writing, Clinical brochures, Product Monographs, Manuscripts, Physician / Patient communications etc.]- Team Lead & Supervisory Roles in Medical Device Companies, Medical Communication Organizations - Degree in Medicine (Complimentary Alternative Medicine, Homeopathy) from Maharashtra University of Health Sciences, Mumbai India; Certification in Homeopathy from Council of Homeopathy, USASpecialties: 1. FDA and Vigilance Reporting/Post market Surveillance, Medical & Regulatory Writing, Drug Safety & Clinical Research, Six Sigma Green Belt2. Classical homeopathy (BHMS, CCH, RShom NA)
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Medical AffairsQ'Apel MedicalMorgan Hill, Ca, Us -
Medical Safety DirectorPhilips Aug 2024 - PresentAmsterdam, Noord-Holland, Nl -
Sr. Medical Safety ManagerMedtronic Apr 2022 - Aug 2024Minneapolis, Mn, Us -
Medical Safety ManagerMedtronic Jan 2018 - Apr 2022Minneapolis, Mn, Us -
Sr. Medical WriterMedtronic May 2017 - Jan 2018Minneapolis, Mn, Us -
Regulatory Post Market Surveillance SupervisorIntuitive Surgical Oct 2015 - Apr 2017California, 94086, Us -
Regulatory Post Market Surveillance Analyst (Contract) At Intuitive Surgical Inc.Advantage Resourcing Apr 2015 - Oct 2015Cincinnati, Ohio, Us -
Honorary Peer ReviewerB.Jain Dec 2014 - Apr 2015Responsible for peer review of homeopathy journal 'The Homoeopathic Heritage'. Providing expertise on related articles pertaining to field of Homeopathy practice subject to journal guidelines and requirements.
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Consultant Medical & Regulatory Writer / EditorFree Lance Sep 2014 - Apr 2015Working with a few clients on virtual basis providing literature reviews, newsletter content, CME modules etc. Published cases on Hpathy.com: http://hpathy.com/clinical-cases/a-case-of-atopic-dermatitis/
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Medical Device Reporting Specialist & Adverse Drug Reporting SpecialistMedtronic Dec 2011 - Aug 2014Minneapolis, Mn, UsPerformed the role of Medical Device Reporting Specialist (MDR), to review and write MDR reports, to comply with FDA reporting timelines and guidelines. This included literature review, clinical case report reviews and CIOMS review for reportability decision and submission. o 21 CFR Part 803, Medical Device Reporting FDA device and adverse event coding•Performed the role of Adverse Drug Reporting Specialist (ADR), to review and write MDR reports, to comply with FDA reporting timelines and guidelines.This included literature review, clinical case report reviews and CIOMS review for reportability decision and submission.o 21 CFR Part 314.80, Adverse Drug Reporting MedDRA coding•Thorough knowledge of FDA regulations related to Medical Device Reporting and Adverse Drug Experience Reporting•Trained MDR-specialist as a SME (Subject Matter Expert) in MDR writing and reviewing•Contributed in continuous improvement initiatives•Maintained awareness of new products, government regulations and requirements•Addressed and expedited product complaints under the company's complaint policy and procedures, and ensured compliance with federal regulations •Performed all responsibilities with the achievement of Customer-Focused Quality as the primary priority and goal -
Clinical Research Specialist (Contractor) At Medtronic Inc.Conch Technologies May 2011 - Dec 2011Memphis, Tennessee, UsPerformed the role of Medical Device Reporting Specialist (MDR), to review and write MDR reports, to comply with FDA reporting timelines and guidelines. This included literature review, clinical case report reviews and CIOMS review for reportability decision and submission. -
Clinical/Regulatory Writing (Remote)Tech Observer Nov 2010 - Apr 2011Paramus, New Jersey, UsRemotely worked on free lance basis with the company's India branch, under the requirements of Mr. Venkat Pola. The job requirements included clinical/regulatory writing and research. -
Sr. Medical EditorAramuc India Ltd Jan 2010 - Apr 2011Performed the role of medical writing and management. Tasks included customized inputs, conceptualizing and proposal pitching, client interaction and ideation. Created a series of pocket-sized handbooks: Epilepsy, insomnia, psoriasis, COPD. Interacted with KOLs (Key Opinion Leaders) to publish case-based handbooks. Led client meetings for project briefings and executed the projects, right from briefing stage to final delivery, with minimal supervision. Responsible for writing customized and review articles for various newsletters, journals and booklets in the field of Medicine. Managed the preparation and designing of posters, presentation kits and patient education leaflets as per client requirements.Honorary Editor of the magazine 'Wellbeing' -
Consultant Medical SpecialistMedulla Innovata Oct 2007 - Dec 2009As a medical specialist in Medualla, I handled several tasks from concept development to proposal pitching. Project pitching, client interaction and co-ordination were a major part of my profile and responsibility while handling big pharmaceutical companies like Pfizer, GSK, Johnson & Johnson to name a few. Preparing marketing and sales training materials as well as presenting them during training periods to a crowd of 100 or people was an excellent experience. Besides the other usual customised inputs, being a part of Jr.Spinal Surg by Dr. P.S. Ramani was my biggest achievement via this firm.
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Clinical Research & WritingChillibreeze - Fast Presentation Design Services Sep 2007 - Dec 2009Shillong, Meghalaya, InI worked for chillibreeze as a free lance medical writer. It is a well streamlined organization catering to a global clientele. They maintain an excellent communication and great rapport with no pressure but freedom is totally the writer's domain. -
Free Lance Medical WriterInfoseek (India) Pvt Ltd Jan 2006 - Oct 2008Infoseek Pvt. Ltd. is an excellent working place for people who are in medical films and documentaries. It is here that I got my experience in writing medical scripts in different fields of medicine and for different audiences as well. The mechanism of action of a molecule or a motivating film on pregnancy and exercise...the short films you see on discovery channels or educational sites...it provided me an amazing opportunity to visualize science and then write for it.
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Medical WriterSanofi Aventis, The Amrit Group Mar 2008 - Sep 2008•Assisted in the management of Phase IV post-marketing surveillance study
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Research AssociateThe Larvol Group Llc Jul 2007 - Feb 2008San Francisco, California, UsA life-science healthcare organisation, The Larvol Group provided me the unique oppurtunity to gain knowledge in clinical and market research of the healthcare industry. -
Desk EditorMediworld Publications Jul 2004 - Jan 2005Mediworld was my first step towards medical writing. It is here under the guidance of Dr. Sanjeev Mallik (Director), Dr. Manas (medico-marketing head) and Jyotsna Paralkar (marketing head) that I took my baby steps into medical writing and editing career. After a 6 month inhouse experience with them I continued to write for them on free lance basis.
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Opd: Medical ExterneeMumbadevi Hospital, Cmp Homeopathic College, India Jan 2003 - Dec 2004Performed the role of an Assistant Homeopathic Medical Doctor in the following depts. EBT, Dermatology, Homeopathic Materia Medica and Surgery.
Queenita Fernandes Skills
Queenita Fernandes Education Details
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Maharashtra University Of Health SciencesHomeopathic Medicine/Homeopathy -
North American Society Of Homeopaths (Nash)Homeopathic Medicine/Homeopathy -
Council Of Homeopthic CertificationClassical Homeopathy -
Mithibai College Of Arts, Chauhan Institute Of Science & Amruthben Jivanlal College Of Com & EconHigher Secondary School -
St. Joseph'S Convent High SchoolPrimary & Senior Secondary School -
Institute For Healthcare Improvement (Ihi)Certificate Professional In Patient Safety
Frequently Asked Questions about Queenita Fernandes
What company does Queenita Fernandes work for?
Queenita Fernandes works for Q'apel Medical
What is Queenita Fernandes's role at the current company?
Queenita Fernandes's current role is Medical Affairs.
What is Queenita Fernandes's email address?
Queenita Fernandes's email address is dr****@****ail.com
What is Queenita Fernandes's direct phone number?
Queenita Fernandes's direct phone number is +195223*****
What schools did Queenita Fernandes attend?
Queenita Fernandes attended Maharashtra University Of Health Sciences, North American Society Of Homeopaths (Nash), Council Of Homeopthic Certification, Mithibai College Of Arts, Chauhan Institute Of Science & Amruthben Jivanlal College Of Com & Econ, St. Joseph's Convent High School, Institute For Healthcare Improvement (Ihi).
What skills is Queenita Fernandes known for?
Queenita Fernandes has skills like Diabetes, Medical Writing, Clinical Trials, Gcp, Training, Ich Gcp, Clinical Research, Medicine, Oncology, Pharmaceutical Industry, Lifesciences, Regulatory Affairs.
Who are Queenita Fernandes's colleagues?
Queenita Fernandes's colleagues are Gabriel Norzagaray, Jundie Lulu Jr, Martijn Van Der Prijt, Dr. Antje Bock, Paul Nguyen, Brian Bollinger, Jennifer Dalley Dresch.
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