Director, Pharmacovigilance Scientist

  • location: Cambridge, MA
  • type: Permanent
  • salary: $185,000 - $230,000 per year
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job description

Director, Pharmacovigilance Scientist

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. We supply prestigious life sciences and biopharma companies with job seekers like you to achieve their business goals. If you're looking for a position where you can serve as an asset to your company while making a difference in others' lives, we have the ideal position for you!

 
location: Cambridge, Massachusetts
job type: Permanent
salary: $185,000 - 230,000 per year
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Join our enthusiastic and collaborative team and make a significant impact on the overall success of our novel messenger RNA approach to drug development. Reporting to the Senior Director of Pharmacovigilance, the PV Scientist will be a key contributor focusing on strategic input, support in clinical trial, perform signal management activities and operational support for all our products throughout the life-cycle. In this new role, the successful candidate will be responsible for the oversight of PV activities, vendor and alliance management, and ongoing process improvement.

RESPONSIBILITIES

  • Providing therapeutic area PV support for our developmental products in close collaboration with senior PV, Clinical and Medical personnel.
  • Oversight of day to day PV operational activities for ours investigational products.
  • Develop and maintain processes that will ensure excellence in global case reporting and assessment, demonstrating accuracy, consistency and compliance with applicable global pharmacovigilance regulations.
  • Oversight of vendor in case management and aggregate reports.
  • Review and provide PV therapeutic area input for development of protocols, IBs, SAPs, CSRs and other relevant project/study documents.
  • Represent Pharmacovigilance on clinical teams and initiatives both within and across functional areas.
  • Assist in usual pharmacovigilance activities including ongoing signal monitoring and regulatory activities.
  • Facilitate cross-functional Safety Review Committee meetings, including coordinating aspects of signal evaluation/safety review activities.
  • Participate in evaluation of potential safety issues in conjunction with senior PV staff, Medical Monitors, and other functional areas as appropriate.
  • Participate in writing of aggregate safety reports (e.g., DSURs), as required.
  • Participate in writing of PV input for regulatory submissions and regulatory responses, collaborating with cross-functional areas as appropriate.
  • Assist with writing and maintenance of Safety Monitoring Plans and Pharmacovigilance Agreements.
  • Oversight of signal evaluation/safety monitoring activities.
  • Assure oversight for the review of aggregate safety data to ensure accuracy, integrity and completeness.
 
qualifications:
  • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background
  • Minimum 8 years relevant medical, scientific/clinical, or pharmaceutical experience, including at least 4 years' experience in PV - experience in vaccine development is required
  • Knowledge of MedDRA terminology and its application
  • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex safety information
  • Experience in the preparation and authoring of individual and aggregate safety reports
  • Demonstrated ability to develop, execute and follow-through complex projects to completion
  • Skilled at working effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
  • Independently motivated, detail oriented and strong problem-solving ability
  • Excellent organizational skills and demonstrated ability to multi-task in a fast-paced environment with changing priorities
  • Excellent written and verbal communication skills with the ability to interact across multiple functions
 
skills: Drug Safety, Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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