As the largest staffing and recruitment agency in the world, we can commit to finding 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. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!
location: Cambridge, Massachusetts
job type: Contract
salary: $118.33 - 183.07 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Provides guidance and subject matter expertise on risk management and risk minimization strategy to an assigned therapeutic area to ensure that product risk management strategies are consistent worldwide
- Provide guidance and subject matter expertise on the structured benefit risk assessment framework and the development of the benefit risk assessment document
- Engages with partner global functions (e.g. Clinical Science, Med Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety
- Provide strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning.
- Support the development of risk management plans (RMPs) in modular format, review RMPs) and ensure alignment with Good Pharmacovigilance Practices and other applicable regulations
- Develop and review risk minimization documents such as additional risk minimization measures (aRMMs) and Risk Evaluation and Mitigation Strategy (REMS)
- Provide subject matter expertise and thoughtful contributions to qualitative and quantitative structured benefit risk assessments
- Provide guidance on incorporation of the patient's perspective into benefit risk activities (e.g. patient preference studies)
- Collaborate with Safety Leads, Clinical Leads, PV scientists and Clinical Research Scientists, and others cross functional teams on benefit risk assessment strategy
- Develop and provide recommendations for appropriate risk management interventions such as direct healthcare professional communications, educational materials, controlled access program
- Provide guidance regarding tracking risk management commitments including utilization of a tracking platform and system improvement assessment
- Monitor and report risk management metrics to ensure compliance
- Provide centralized support, training and leadership for safety and cross-functional members who work on risk management plans and risk minimizations activities.
- Support inspections and audits activities with regards to risk management processes
- Perform other duties as defined in standard operation procedures or requested by supervisor.
qualifications:
- Associate Director: PhD/PharmD/DO/MD + 4 years; OR Masters + 7 years; OR Bachelors + 10 years
- Minimum 2 years in PV/safety OR clinical development preferred
- Minimum 3 years of pharmaceutical industry/drug development experience
- Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures and/or REMS programs preferred
- Strong track record of scientific and analytical thinking
- Experience presenting to technical and lay groups at public meetings is desirable
- Demonstrate integrity and work productively in a high-pressure environment
- Good analytical/judgment capabilities to understand/analyze/synthesize and communicate Project Management abilities
- Ability to identify and understand proactively the interactions necessary for achieving business goals and objectives
- Able to manage both time and priority constraints and to manage multiple priorities simultaneously
- Attention to details, computer literacy, knowledge of safety databases
- Take initiative and autonomous action
- Proven ability to work in an international environment and with cross-functional teams, with good interpersonal skills / assertiveness / team spirit / coaching skills
skills: Risk Evaluation and Mitigation Strategies (REMS)
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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
