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location: Cambridge, Massachusetts
job type: Permanent
salary: $185,000 - 230,000 per year
work hours: 9 to 5
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.
- 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.