Pharmacovigilance (PV) Compliance & Training Leader
Posted 1/24/2017 4:12:09 PM
Business Segment: Healthcare Life Sciences
Location(s): United States ; Massachusetts; Marlborough
About Us: GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
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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Role Summary: The Pharmacovigilance (PV) Compliance & Training Leader will assist the Head of Global Pharmacovigilance Compliance and Training in day to day global compliance activities.
The PV Compliance and Training Leader will assist the Head of Global PV Compliance and Training in all aspects of maintaining a global PV quality system including Standard Operating Procedures, quality documents, compliance measures, audit/inspection readiness and training
Serve as a liaison between Central Safety Unit (CSU) and Global PV network including Local Safety Units (LSUs), distributors, wholesalers and partners
Provide PV training to Global PV Network (LSUs, distributors and partners)
As needed, provide PV training to GEHC employees or those working on behalf of GEHC
Perform ongoing monitoring of compliance, metrics and performance data
Provide detailed root cause analysis of non-compliant single case reports (late cases) and aggregate reports
Serve as key resource person in inspections and audits
Perform reconciliation of safety information including AE tracking logs from PV network and reconciliation for product quality complaints
Perform quality assurance, report achieved quality levels and recommend revision of quality documents, user guides and training materials
Collaborate with internal and external partners on issues and activities related to quality, compliance and case processing activities
Interpret and apply changing global regulations and guidance pertaining to product safety and pharmacovigilance (clinical and post marketing)
Participate in teams and committees as assigned
Ability to travel to other locations for PV meetings, trainings
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 4. Knowledge and understanding of GEHC MD QS on Pharmacovigilance and the Global Pharmacovigilance procedures
RN, NP or PharmD degree with clinical experience
Minimum of 6 years of pharmaceutical/biotechnology industry experience in PV including clinical trial and post-marketing. Global experience preferred.
At least 4 years of pharmacovigilance quality management experience
Demonstrated mastery of the activities and processes related to single case processing and aggregate reporting. Signal detection and risk management experience helpful
Prior regulatory inspections experience
Proficient in US/EU/AP/LA regulations and ICH guidelines
Exposure to working relationship with FDA and other regulatory authorities
Strong oral and written communication and interpersonal skills
Ability to travel domestically or internationally up to 10% of the time
Ability to work with interdisciplinary, highly matrixed teams
Global experience preferred
Locations: United States ; Massachusetts; Marlborough
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