Experience

Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Drug safety associate

  • Sep 2014 - Present

  Overall processing of adverse event (AE) information in compliance with applicable FDA and global regulations and Actelion Standard Operating Procedures (SOPs) and guidelines • Ensures accurate data entry and the timely processing of AE reports including writing meaningful case narratives in Argus • Create queries for AE report clarification • Track AE information and prepare administrative reports for management • Participate in assessing whether a case should be downgraded to upgraded in seriousness after initial and follow-up information • Assist in developing and maintaining standard global procedures and guidelines for Drug Safety operations • Review, evaluate and assess adverse event information for regulatory reporting • Assist in the preparation of internal and external reports including metric reports and aggregate reports per US and international regulations • Create and generate safety information for internal use, and safety review boards • Interact with other Actelion Drug Safety units in the review, processing, and reporting of safety information • Participate in/attend clinical team meetings when appropriate, provide technical advice and support to the clinical team • Represent the Drug Safety Department in other company team meetings or conferences • Contribute to inspection readiness planning, as needed • Participate in validation of safety database upgrades, as needed • Mentors internal sources and participates in Safety Operations training initiatives



Covance

• United States
• Research Services
• 700 & Above Employee

• Drug Safety Associate

  • Jul 2012 - Aug 2014

  Responsible for managing the receipt and processing of all adverse event reports reported either spontaneously from any source or from clinical trials, including, but not limited to: o Entering of safety data onto adverse event database systems and tracking systems o Review of adverse events for completeness, accuracy and appropriateness for expedited reporting o Writing case narratives o Coding adverse events accurately using MeDRA o Determining expectedness and listedness against appropriate label o Identifying clinically significant information missing from initial reports and ensuring its collection o Ensuring cases receive appropriate medical review o Preparing follow-up correspondence consulting the medical staff accordingly o Ensuring all cases that require expedited reporting to worldwide regulatory agencies are processed swiftly and appropriately within required timelines



Actavis

• NJ

• Pharmacovigilance assistant

  • Apr 2011 - Jun 2012

  Responsible for data entry of preliminary and follow-up information from source documents into an adverse event database. • Prepared a medical narrative and generated regulatory reports including CIOMS I and MedWatch. • Coded all adverse events using MedDRA terminology. • Responsible for reconciliation and verification of adverse event reports with global affiliates. • Processed serious cases reportable to the FDA and international regulatory agencies. • Assisted in the compilation of working practice documents for departmental process conventions. • Provided training to new and current colleagues and contractors. • Responsible for electronic submissions of serious adverse event reports to European regulatory agencies. • Assisted in the generation of aggregate reports. • Performed monthly reconciliation with other departments and licensing partners to assist in maintaining compliance. • Monitored outsourcing vendor for quality of adverse event reports. • Member of planning and presentation team for off-site departmental meetings on MedDRA coding and pharmacovigilance. • Member of audit/inspection readiness team.