9 days old

Global Compliance and Training Leader, PV and MA

GE Energy
Marlborough, MA 01752
  • Jobs Rated
    25th
Role Summary:This role is part of the GEHC Global Medical Services (GMS) organization which includes Pharmacovigilance (PV) and Medical Affairs (MA). This individual will perform various activities that pertain to the quality management system in PV and MA including document management and training activities. This individual may be responsible for documenting and monitoring safety information exchange with Local Safety Units (LSUs), distributors and third parties to ensure the receipt and reporting.

Essential Responsibilities:



+ Maintain PV network (Local Safety Units/Distributors) database documentation including contact information for PV responsible persons, PV agreement status, local regulatory reporting requirements and local training records



+ Perform reconciliation of safety information tracking logs from PV network to ensure compliance of submissions to CSU and regulatory agencies



+ Participate in MA and PV Compliance and Training governance activities. Including preparation of metrics and reporting to GMS



+ Work with QA colleagues to perform reconciliation for product complaints



+ Perform Quality Control assessments including source document verification check of reports entered into safety database



+ Adhere to PV responsibilities outlined in third-party agreements (distributor, contractor, collaborative partners).



+ Track safety data exchange information to ensure compliance with SDEA



+ Identify noncompliance and contribute to the investigation and development of corrective and preventive action plans



+ Provide support as needed during audits and inspections







Qualifications/Requirements:



+ Minimum of a Bachelor of Science degree with RN or Pharmacy Degree preferred or a High School diploma/GED and minimum 4 years work experience in a Quality or Regulatory Assurance related field



+ Minimum of 3 years in pharmaceutical/biotechnology industry experience in PV, including clinical trials and post marketing experience.



+ Proficient in US/EU/AP/LA regulations and ICH guidelines



+ Proficiency working in Windows-based word processing and medical/scientific/regulatory databases/resources



+ Experience with document management systems (Standard Operating Procedure management for example)



+ Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal history, and educational background









Desired Characteristics:



+ High integrity, sense of urgency, ability to recognize time sensitivity, willingness to work in a matrix environment and assume the role of player/coach as necessary



+ Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills









About Us:With 4000+ employees serving 100+ countries, GE Healthcares Pharmaceutical Diagnostics (PDx) business is the number one global supplier of contrast media and molecular imaging agents used in medical imaging exams to improve the visibility of organs, blood vessels or tissues, often helping radiologists distinguish between normal and abnormal conditions. PDx products makes a huge impact worldwide - supporting three patients every second.

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Additional Eligibility Qualifications: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).Additional Locations:Norway, United States;Massachusetts;Marlborough or Oslo;

Categories

Jobs Rated Reports for Compliance Officer

Posted: 2020-10-13 Expires: 2020-11-12

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Global Compliance and Training Leader, PV and MA

GE Energy
Marlborough, MA 01752

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Compliance Officer
25th2018 - Compliance Officer
Overall Rating: 25/220
Median Salary: $67,870

Work Environment
Very Good
22/220
Stress
Very Low
2/220
Growth
Poor
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