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Opening to work as Manager, Pharmacovigilance in inVentiv Health

 

Clinical courses

inVentiv Health Clinical, a leader in drug development services, has a global infrastructure, therapeutic expertise, and commitment to quality that is unmatched in the industry. For pharmaceutical, biotechnology, generic drug, and medical device companies of all sizes around the world, inVentiv Health Clinical can help you transform promising ideas into commercial reality.

Post: Manager, Pharmacovigilance

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: 9610
Location:
Pune
/ Hyderabad
Industry Type: Clinical Research
Functional Area: Pharmacovigilance, CR
Last Date: 15th May, 2015

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