Manager, Pharmacovigilance @ inVentiv Health B1

Job Description

• Provide day to day managerial oversight to the Pharmacovigilance staff
  
• Perform quality control review of completed individual and periodic safety reports and ensure compliance with regulatory reporting requirements
  
• Prepare and/or review expedited Safety Reports for submission to Regulatory Authorities
  
• Communicate with Clinical Research and clients to ensure compliance with drug safety and Pharmacovigilance SOPs
  
• Be the safety lead for projects; to include set-up, project management client liaison
  
• Mentor Safety Associates and other members of the Global Safety and Pharmacovigilance group involved in safety data processing
  
• Perform training of safety reporting requirements for other PharmaNet departments.
  
• Be responsible for SAE reconciliation for a study
  
• Ensure that PharmaNet is in compliance with safety reporting requirements of regulatory authorities
  
• Ensure that PharmaNet meets client expectations and requirements for safety reporting
  
• Provide regulatory consultation regarding safety reporting for investigational drugs
  
• Review serious adverse experience information received form investigative sites and assures compliance with reporting requirements
  
• Prepare/review safety section of regulatory reports, e.g. Annual Reports and Periodic Safety Update Reports
  
• Prepare SAE reporting plans
  
• Represent Global Safety and Pharmacovigilance group at project team, client and Investigator meetings
  
• Prepare documents describing the process for monitoring and reporting serious adverse experience (e.g., SOP, user manuals)
  
• Maintain proficiency in current knowledge of all applicable regulatory guidelines and regulations relating to safety reporting
  
• Coordinate with Medical Affairs, Clinical Research and Data Management for the efficient and timely review of safety information at PharmaNet
  
• Assist Business Development for client development presentations that involve safety reporting as a potential service: provide adequate input into client proposals
  
• Act as project manager for stand-alone Safety and Pharmacovigilance projects
  

Candidate Profile

• Bachelor’s Degree in a life science or nursing; or RN diploma
  
• Six years relevant experience in Safety/Pharmacovigilance required which may include up to 2 years of data management, CRA, clinical practice (RN, RPN). Health authority of study coordinator experience
  
• Good Verbal and written communication skills
  
• Excellent Knowledge of ICH guidelines and regulation relating to Pharmacovigilance
  
• Demonstrate working knowledge in MS Office applications
  
• Ability and willingness to travel (~20%)
  

Additional Information:
Experience: 6 Year
Job ID: 7493
Location: Pune
Industry Type: Clinical Research
Functional Area: Pharmacovigilance, CR
Last Date: 31^st July, 2014

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