Safety Governance Project Manager (Pharmacovigilance Operations)
Hybrid - Cambridge, MA (5 days/month onsite)
6-Month Contract
Must Have Experience
Pharmacovigilance Operations & Governance
SOP / Process Development & Maintenance
CAPA & RSI Oversight
Project Management Tools & Frameworks
KPI / Metrics Reporting
- Partners with the company Safety Board Chair to enable its operational excellence
- Provides project management leadership to facilitate Safety Board processes and activities including escalation and company-wide communication
- Ensures training on Safety Board processes, and continuous improvement by incorporating learnings into ways of working and performance measurement
- Functions as Business Process Owner (BPO) for Data Monitoring Committee (DMC), Internal Review Committee (IRC), and First in Human Committee (FiH)
- Takes the lead on additional assigned projects to drive organizational goals and operational excellence
- Acts as SME overseeing the Reference Safety Information (RSI) CAPA-related activities
- Oversees PSPV business continuity plan, monthly department meetings, and PSPV Satori Council
location: Cambridge, Massachusetts
job type: Contract
salary: $85 - 98 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Partners with Global Project Leaders, Global Safety leads, PSPV Therapeutic Areas Heads, and other senior leaders to collect and analyze information supporting the decision-making process to trigger a Safety Board interaction (e.g. ad hoc Meeting, Milestones Review or Forum)
- Collaborates with the Safety Board Chair, PRC office & PSPV Therapeutic Area Heads to initiate and triage Safety Board interactions in alignment with established governances and processes (e.g. Other Important Safety Information, Safety Management Team, GLOC, QAM, PCMC).
- Oversees logistics and project management of Safety Board activities
- Maintains Safety Board materials in centralized location, ensuring adequate access to information such as pre-read, meeting minutes, and closeout of all action items
- Maintains Safety Board processes (e.g. SOP, training slides, playbook), and oversees training to ensure understanding of Safety Board readiness and operating model
- Expedites escalation, decision making and communication related to Safety Board activities.
- Analyses and reports Safety Board performance based on strategic and business goals, working with Safety Board Chair to measure against Key Performance Indicators (KPIs).
- Functions as the Business Process owner for Data Monitoring Committee (DMC), Internal Review Committee (IRC) and First in Human Committee (FiH)
- Sets the strategic direction for the process, in coordination with functional experts.
- Leads developing, authoring, maintaining & approving procedural document (SOP), operating model RACI, associated templates / forms, training material, technology capabilities.
- Liaises with other stakeholders (peer function, quality), ensuring cross-function alignment and escalating issues to sponsors.
- Develops global training needs in collaboration with Process, Training and Digital Solutions (PTDS).
- As a member of the Strategy and Operations Team, provides input to key strategic & portfolio activities that may include:
- Project management support for PSPV initiatives, change-management activities and organization of department meetings.
- Supports business analytics and key initiatives enabling operational deliverables aligned with organizations goals.
- Supports PSPV business continuity plan and PSPV Satori Council
- Foster and maintain an engaging culture and continuously improve PSPVs ways of working.
- Acts as SME overseeing the Reference Safety Information (RSI) CAPA-related activities
qualifications:
- Bachelor' Degree in Science or Business. Advanced Degree preferred.
- 8-12+ years' experience in pharmacovigilance operations, clinical governance, or safety program management within a global pharma/biotech environment.
- Proven leadership in Safety Board or DMC governance, including process ownership, documentation, and stakeholder coordination.
- Demonstrated expertise in SOP authorship, CAPA management, and RSI maintenance supporting regulatory inspection readiness.
- Strong proficiency in project management systems (Smartsheet, MS Project, SharePoint, or equivalent) and data tracking/reporting tools.
- Excellent communication and presentation skills, with a record of executive-level engagement across PV, Clinical, and Regulatory functions.
- Some domestic and international may be required on an infrequent basis
skills: Project Management, Pharmacovigilance, Drug Safety, PV CAPA Management
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.
