Pharmacovigilance Scientist

job summary: This high-level, remote contract role offers a premium compensation of $100-$111 per hour for an experienced Pharmacovigilance Scientist looking to lead critical safety operations within a sophisticated clinical environment. You will serve as a primary lead in the signal management process, driving signal detection and tracking while synthesizing complex data to author high-impact evaluation reports. This position provides a unique opportunity to oversee Aggregate Report management (including PSURs, DSURs, and RMPs) and collaborate directly with Global Safety Officers to align safety strategies for investigational programs. If you possess 7+ years of PV experience, a mastery of MedDRA terminology, and the analytical rigor to manage competing regulatory priorities, this 7.5-month engagement is an ideal platform to showcase your expertise in global drug safety and risk communication. location: Telecommute job type: Contract salary: $100 - 111 per hour work hours: 9 to 5 education: Bachelors responsibilities:

• Support and/or leads the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Support and/or leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.
• Support and/or leads process for responding to safety questions from regulatory authorities while collaborating with cross-functional team as necessary.
• Support and/or leads Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Plans (REMS), and Risk Management Plans (RMPs).
• Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned to ensure alignment with safety strategy and risk communications.
• Responsible for day-to-day safety operations and safety management plans for assigned clinical trials

qualifications: Required:

• Minimum 7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management experience.
• Bachelor's Degree in biologic or natural science; or health case discipline required.
• Knowledge of MedDRA terminology and its application
• Must have excellent analytical and problem-solving ability
• Strong computer skills and advanced application MS capability desirable, particularly Excel
• Ability to work in fast-paced environment with multiple competing priorities

Preferred:

• Advanced degree (PhD, MPH, NP, PharmD, etc.).

#LI-KH1 skills: Pharmacovigilance, Signal Detection, Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), Risk Management Plan (RMP), Informed Consent Form (ICF) 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 [email protected]. 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. Apply tot his job Apply To this Job