Pharmacovigilance Global Coordinator

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IT Staffing Done Right the First Time

Software Specialists is an IT staffing company with extensive consulting experience in the Information Technology Industry. Incorporated in the state of Pennsylvania in 1998, we bring 15 years of experience in providing IT talent to FORTUNE 1000 Companies.

Our experience from providing thousands of IT consultants has taught us that customers require contractors with more than just the technical knowledge. Team work, cultural fit, and attitude are just as important as aptitude. Be it 1 position or 100 positions, Software Specialists' focus is on finding the "Smart Fit" for our clients' needs; this makes us not just one of the fastest growing Information Technology consulting firms in the country but also a trusted adviser to our customers in their talent acquisition process.

ACTUAL TITLE - PHARMA COVIGILANCE GLOBAL COORDINATOR (12 MONTHS ASSIGNMENT)

PAY: $34.63/hr

The Pharma covigilance (PV) Global Coordinator is responsible for interacting proactively with Local Safety Units (LSUs) and distributors to ensure that all adverse event reports received locally are reported to GEHC PV Central Safety Unit (CSU) in a timely manner as specified in PV SOPs. Responsible for distribution of adverse event reports to LSUs and distributors, monitoring and managing the electronic export and import of adverse event reports from global regulatory authorities.

Specific responsibilities include, but are not limited to the following:

Interact proactively with LSUs and distributors to ensure that all adverse event reports received locally are reported to the CSU unit in a timely manner as specified in PV SOPs

Monitor workflow status of adverse event reports in the ARISg global safety database to ensure compliance with case processing timelines

Perform daily review of ARISg 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 and address transmission errors

Generate submission confirmations for placement in hardcopy file

Monitor electronic imports into ARISg and submit to workflow for processing

Assist with other case processing activities as needed

Assist with scheduling and coordinating the preparation and submission of aggregate safety reports

Bachelors of Science degree

Minimum 2 years of pharmaceutical/biotechnology industry with experience in pharmacovigilance including clinical trials and post marketing.

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 (ARISg highly preferred)

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)

Must be legally authorized to work in the United States

Must be willing to work in our Princeton, NJ facility

Must be willing to submit to a drug test and background check

Must submit application for employment through our website to be considered

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 background investigation and drug screen.

High integrity, sense of urgency, ability to recognize time sensitivity

Excellent organizational and interpersonal skills

Strong oral and written communication skills

Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances

External Focus:
Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment