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PV Operations Manager

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Cambridge, MA
$55.00 - $95.00
Job Type
Oct 26, 2016
Job ID
Responsible for Pharmacovigilance Operations activities for all safety reports received from any source (clinical trials and post-marketing) for assigned products and/or studies, according to ICH-GCP guidelines, regulatory requirements and company SOPs, policies and procedures. 

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES: To perform this job successfully, an individual must be able to perform each key function satisfactorily. Reasonable accommodations may be made to enable individuals with disabilities to perform the key functions as determined through an interactive discussion with the employee and in consultation with HR and Legal. 
Ensures accuracy of triage, assessment and processing of adverse events in the Global Safety Database 
Ensures compliance with federal regulations and standard operating procedures. 
Collaborates with medical staff regarding adverse event/safety issues. 
Collaborates with cross-functional teams to create IND reports and aggregate reports 
Communicates with partner companies, collaborative sponsors and respective clinical research organizations (CROs) regarding evaluation and processing of case reports 
Determines necessary follow-up for missing, discrepant or additional information/source documentation for each case using medical, product and regulatory knowledge and ensures that required follow-up for assigned cases has been completed; 

Working hours: 8:30-5:30 

QUALIFICATIONS: The requirements listed below are representative of the knowledge, skill and/or ability required. 
Degree and healthcare background required (BS/RN/NP/PA/RPH) 
Strong clinical background required, oncology experience preferred 
Understanding of local and applicable foreign safety regulations 
Working knowledge of relevant regulations and guidance documents governing both safety reporting and processing for clinical trial and post-marketing environment 
Detailed knowledge in the use of drug safety databases (Argus) 
Practical experience working with MedDRA required 
Excellent interpersonal, influencing and negotiation skills 
Strong verbal and written communications and presentation skills 
Proven problem solving and decision making skills 
Excellent leadership, management, planning and project management skills