Medical Director, Pharmacovigilance (PV) Physician

Location: Rockland, MA
Job Type: Contract
Salary: $100,000.00 - $110,000.00
Hourly: $150.00 - $175.00
Degree: Doctorate;
Date: 11/9/2017
Job ID: 02535006
Job Description
Medical director needed for Global Pharmaceutical company with US Headquarters in Massachusetts


The role of the Medical Director, GPSI–US is to provide medical management and leadership for processing and analyzing safety reports for assigned compounds. 
The role is responsible for the overall safety assessment, pharmacovigilance activities, US label review, US periodic aggregate reports, and regulatory reporting activities for marketed/investigational products. The position also provides and monitors for accurate and consistent medical assessment of adverse event reports per company SOPs and in compliance with regulatory requirements. 
Who You Are 
• MD Required (or international equivalent) with accredited residency 
• Minimum of five years of experience in drug safety and pharmacovigilance in the pharmaceutical or biotech industry 
• Demonstrated management skills 
• Good organizational, leadership, written and verbal communication skills 
• Demonstrated sound medical opinion and comprehensive understanding of product’s label and core safety information 
• Fluency in English 
• Additional languages are a plus 
• Detailed knowledge of FDA and global regulatory authorities (i.e., ICH, EMEA) regulations in drug safety and pharmacovigilance practices 
• Experience with safety database (ARISg) 
• Ability to retrieve, analyze and present safety data 
• Commitment to ethics and regulatory standards 
• Convincing and effective communicator 
• Ability to work in a fast-paced environment, multi-tasking and prioritizing 
• Oriented towards efficiency and results driven 
• Creative, self-motivated and team player