Experience

Novavax

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Product Safety Specialist

  • Apr 2016 - Present

  • Perform Quality Review of safety reports in clinical trials (vaccines) in elderly and maternal/fetal populations. • Perform triage, assign priority and classify incoming SAEs according to regulatory reporting criteria.• Evaluate cases for seriousness, relatedness, and expectedness according to the protocol and/or investigator brochure.• Confirm presence of adequate information needed to perform case evaluation, and review relevant source documents for consistency and verification of adverse event data.• Initiate follow-up activities via queries to investigative sites as needed, to retrieve missing information, according to SAE reporting requirements, regulatory guidelines, and department SOPs.• Perform MedDRA coding, as per SOPs and guidelines.• Prepare narratives, according to approved template.• Adhere to required timelines for processing SAE reports. • Ensure that product specific reports are prepared and submitted in accordance with departmental and company guidelines.• Maintain a thorough understanding and strict adherence to GCP guidelines and regulatory reporting regulations.



Bayer Healthcare Pharmaceuticals

• Medical Records Litigation Extraction Specialist/PV Clinical Safety Associate

  • Apr 2014 - Apr 2016

  Review/analyze/extract pertinent information in a timely manner from medical records in litigationCreate comprehensive narratives in accordance with legal and US FDA safety regulationsIndependent decision making/strong prioritization skills



IQVIA

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Associate Operations Specialist

  • Nov 2011 - Jan 2014

  Diiachi Sankyo Cardiology Clinical Trial



Bayer Healthcare Pharmaceuticals

• Medical Records Litigation Extraction Specialist/PV Clinical Safety Associate

  • Sep 2010 - Nov 2011

  Review/analyze/extract pertinent information in a timely manner from medical records in litigationCreate comprehensive narratives in accordance with legal and US FDA safety regulationsIndependent decision making/strong prioritization skills



Bayer Healthcare

• Medical Records Extraction Specialist/ PV Clinical Safety Associate

  • Sep 2010 - Nov 2011



Schering-Plouth/Merck Pharmaceuticals

• Associate Manager/ Drug Safety Specialist

  • Dec 2007 - Sep 2010

  Safety reporting (clinical trials/Oncology)-US/globalTimely follow-up/query submission for case reconciliationIndependent/accurate medical assessment of cases Adherence to strict timelines Verification of protocol-specific data



Sanofi-Aventis Pharmaceuticals

• Affiliate Safety Associate

  • Jul 2006 - Oct 2007

  Safety reporting Medra/WHO DRL coding Narrative writing; Review of literature reports; legal casesTimely follow-up on serious/non-serious cases/clinical trials.