A top-tier global biopharmaceutical leader is seeking a PV Aggregate Reports Scientist to join the Safety Surveillance and Aggregate (SSA) Reports team. In this pivotal role, you will act as a subject matter expert on worldwide aggregate safety reporting requirements and drive end-to-end management of critical safety documents to support global compliance.
location: Cambridge, Massachusetts
job type: Contract
salary: $65 - 77 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Independently author, project manage, and oversee PSURs, DSURs, PADERs, and local aggregate safety reports.
- Serve as the global subject matter expert on safety requirements, providing guidance across cross-functional teams.
- Monitor global pharmacovigilance legislation updates, conduct impact assessments, and maintain the Aggregate Reports Master Schedule.
- Support authoring responses to regulatory authority safety inquiries in collaboration with PV Scientists and key stakeholders.
- Lead process improvement initiatives to enhance aggregate reporting, signal management, and safety oversight efficiency.
qualifications:
Required:
- Bachelor's degree in biological or natural sciences.
- Minimum of 5 years of Pharmacovigilance experience, including direct experience writing aggregate safety reports and managing safety signals.
- Strong knowledge of drug safety regulations, clinical trial safety, and post-marketing safety processes.
- Proven ability to analyze and present complex medical data clearly to cross-functional partners.
- Experience with safety database systems and standard office software.
- Advanced degree (MSc, PhD, MPH, PharmD, or equivalent).
skills: Pharmacovigilance, Drug Safety, Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), Periodic Safety Update Report (PSUR)
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.
