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Robin Elder is listed as Retired based in Green Lane, Pennsylvania, United States. AeroLeads shows a work email signal at inovio.com and a matched LinkedIn profile for Robin Elder.
Robin Elder previously worked as Director, Global Clinical Safety and Pharmacovigilance Operations at Inovio Pharmaceuticals, Inc. and Medical Writer III / Product Safety Evaluation Scientist at Janssen, Pharmaceutical Companies Of Johnson & Johnson (Converted To Employee Post 2-Yr Contract). Robin Elder holds Bachelor Of Science (Bs), Medical Technology from Rutgers University.
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Pharmaceutical professional with large global and small pharmaceutical experience, concentrated in Pharmacovigilance/Drug Safety with active support of Research & Development, Clinical Operations, Quality Assurance, Regulatory Affairs, and Medical Affairs.Strong medical writing experience, including authoring narrative summaries and regulatory safety reports for serious adverse events in oncology, cardiovascular, central nervous system, gastrointestinal, hormone replacement, endocrine, respiratory and inflammatory disease, and pain management therapeutic areas. Supported successful NDA and sNDA submissions for cardiovascular, oncology, and gastrointestinal products. Superior communication, writing, and interpersonal skills, and firm understanding of current FDA, ICH, and GCP regulations.
Listed skills include Pharmacovigilance, Drug Safety, Meddra, Rems, and 1 others.
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Plymouth Meeting, PA
Develop and manage investigational clinical trial safety data reporting processes and direct planning and strategic decisions to support safety responsibilities for marketed products.
Horsham, PA
Medical writing projects include ad hoc analysis, health hazard evaluation, addendum to clinical overview, and aggregate regulatory reports across multiple therapeutic areas. Responsibilities involve strategy development, aggregate safety analysis and case level review, analysis and summary of safety-related issues to support risk-management activities.
Exton, PA
Developed, documented, and managed investigational clinical trial and post-marketing adverse event reporting processes and aggregate analysis strategies to ensure compliance with FDA regulations, ICH guidelines, and Risk Mitigation and Evaluation Strategy (REMS) requirements.Provided content to support pharmacovigilance monitoring, reporting and analysis.
Managed serious adverse event processes, expedite reporting, workflow management and signal detection for clinical trials in oncology, cardiovascular, central nervous system, hormone replacement, and endocrine (diabetes, Type 2), and respiratory and inflammatory disease therapeutic areas.
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Robin Elder is listed as Retired.
AeroLeads has found 1 work email signal at @inovio.com for Robin Elder.
Robin Elder is based in Green Lane, Pennsylvania, United States.
Robin Elder has worked for Inovio Pharmaceuticals, Inc., Janssen, Pharmaceutical Companies Of Johnson & Johnson (Converted To Employee Post 2-Yr Contract), Adolor Corporation (Acquired By Cubist Pharmaceuticals, Dec 2011), and Glaxosmithkline.
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Robin Elder holds Bachelor Of Science (Bs), Medical Technology from Rutgers University.
Robin Elder is listed with skills including Pharmacovigilance, Drug Safety, Meddra, Rems, and Adverse Event Reporting.
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