General Electric Sr. Clinical Drug Safety Specialist in Marlborough, Massachusetts
This role provides drug safety and pharmacovigilance (PV) support for new and ongoing clinical trials. Individual is responsible for all activities related to the Global Drug Safety and PV (GPV) Central Safety Unit (CSU) processing of Individual Case Safety Report (ICSR) information from all sources. This individual codes serious events and synthesizes complex clinical information into accurate and complete narratives, as well as oversees PV outsourced clinical trial activities.
• Reviews serious adverse event (SAE) reports from clinical trials to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data.
• Oversees vendors’ activities including development of SMP ( safety management plans), SAE management and safety database training
• Ensures vendors produce quality outputs/tables from the safety database system (Argus) to support safety review, DMC meetings and safety document creation.
• Interacts with PV vendors and Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and the prescriber community
• Develops, participates and ensures the periodic internal safety review meetings/process
• Contributes to the development, management and generation of SOPs for pharmacovigilance and drug safety monitoring. Evaluates and identifies areas that may require improvement or clarification and drafts procedural changes and adaptations as needed. Develops and implements internal pharmacovigilance guidelines, processes
• Serve as pharmacovigilance liaison and resource to internal and external groups (e.g., regulatory affairs, medical affairs, clinical development teams, CROs, etc) on issues related to pharmacovigilance
• Receive, triage and process adverse event and medical device reports from all sources including post-marketing, clinical trials and published literature
• Perform initial assessment of seriousness, expectedness, causality, and reportability in accordance with GPV processes and global regulatory requirements and guidelines
• Perform data entry and quality review of adverse event reports into the global adverse event database, including accurate coding of MedDRA terms and preparation of case narratives
• Identify missing or discrepant information and perform active case follow-up via verbal or written contact
• Prepare expedited reports for submission to regulatory authorities and ethics committee
• Support safety physicians in handling issues related to both clinical and post-marketing safety, as needed
• Support preparation and submission of aggregate reports including PSURs, DSURs, and US Periodic Reports, as needed
• Serve as pharmacovigilance resource during inspections and audits
• BS in a scientific area or healthcare and years of progressively responsible experience in drug safety/pharmacovigilance in the pharmaceutical/biotechnology industry; or equivalent. RN is preferred
• Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing both safety reporting and case processing for clinical trial environments.
• Demonstrated knowledge and experience in the regulatory requirements for clinical trial documents and reporting, including protocol development, data collection and analysis, and preparation of key clinical trial documents (e.g SMP)
• Proficient in all aspects of case processing, including case assessment (seriousness, expectedness, reportability), narrative writing, MedDRA coding, quality review and SUSAR/ICSR reporting
• Experience with drug development and Phase I-III studies process and post marketing processes and regulations is required
• Understanding of Microsoft office applications, specifically Excel and Word
• 8 years of progressively responsible experience in drug safety/pharmacovigilance in the pharmaceutical/biotechnology industry; or equivalent. RN is preferred
• Solid communication, writing, and interpersonal skills with the ability to communicate technical information effectively verbally and in writing
• Ability to work collaboratively and independently
• Strong planning and organizational skills; detail-oriented
• Experience with Argus preferred
There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than
11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE
Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the
journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge
technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future.
We are accelerating biology to cell therapy in ways no other company can.
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GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%20EEO%20combined.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.
Locations: United States; Massachusetts; Marlborough
GE will only employ those who are legally authorized to work in the United States for this opening.