Job Information
General Electric Drug Safety Associate in Marlborough, Massachusetts
Job Description Summary
The Global Drug Safety Associate interacts proactively with Local Safety Units (LSUs) and distributors to ensure that all adverse event reports received locally are reported to the GEHC Pharmacovigilance (PV) Central Safety Unit (CSU) in a timely manner as specified in PV SOPs. This individual is also responsible for distributing adverse event reports to LSUs and distributors and for monitoring and managing the electronic export and import of adverse event reports from global regulatory authorities.
Job Description
Role Summary/Purpose
The Global Drug Safety Associate interacts proactively with Local Safety Units (LSUs) and distributors to ensure that all adverse event reports received locally are reported to the GEHC Pharmacovigilance (PV) Central Safety Unit (CSU) in a timely manner as specified in PV SOPs. This individual is also responsible for distributing adverse event reports to LSUs and distributors and for monitoring and managing the electronic export and import of adverse event reports from global regulatory authorities.
Essential Responsibilities
Interact proactively with LSUs and distributors to ensure that all adverse event reports received locally are reported to the GEHC CSU unit in a timely manner as specified in PV SOPs Monitor workflow status of adverse event reports in the global adverse event database to ensure compliance with case processing timelines
Perform daily review in global adverse event database to ensure distribution of adverse event reports to LSUs, distributors and partners
Monitor acknowledgment receipts/responses from electronic submissions of adverse event reports to global regulatory authorities, LSUs, Partners and Distributors and address transmission errors
Monitor electronic imports into global adverse event database and submit to workflow for processing
Assist with other case processing activities as needed
Performs other duties and responsibilities as assigned
Quality Specific Goals:
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Complete all planned Quality & Compliance training within the defined deadlines.
Identify and report any quality or compliance concerns and take immediate corrective action as required
Qualifications/Requirements
Bachelor of Science degree (Life Sciences Background)
Minimum of 2 years of pharmaceutical/biotechnology industry with experience in
Pharmacovigilance/regulatory affairs including clinical trials and postmarketing. Global experience highly preferred.
In-depth knowledge of Individual Case Safety Report (ICSR) processing with hands-on experience coordinating and monitoring ICSR workflows and reporting ICSRs to global regulatory agencies
Proficient in performing data entry, retrieval and electronic reporting in global drug safety databases
Familiar with US/EU/AP/LA regulations and ICH guidelines pertaining to adverse event reporting
Proficient in use of Microsoft Office (Word, Excel, PowerPoint, Outlook)
Desired Characteristics
High integrity, sense of urgency and ability to recognize time sensitivity
Excellent organizational, interpersonal skills, problem solving and negotiation skills
Excellent written and verbal communication skills
Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations
Additional Information
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer (https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf) . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
Relocation Assistance Provided: No