Sr. Pharmacovigilance (PV) Operations Manager | Remote | West Coast
This critical role is responsible for managing and overseeing PV operations across clinical development programs, ensuring seamless collaboration with PV vendors. You will play a key role in preparing for the initiation of two global Phase 3 trials, ensuring all PV activities are in place. Your expertise in global trial management, study document review, and vendor oversight will directly impact patient safety and the strategic direction of our product lifecycle, with a strong focus on quality and compliance.
MUST HAVE
- Bachelor's Degree
- 5+ years of Pharmacovigilance experience in Pharma or Biotech
- Experience in PV Operations, overseeing case processing operations
- Strong knowledge of global safety regulations (FDA, ICH, EU) & ICSR case processing
- Experience overseeing PV Vendors to include KPI monitoring & compliance management
location: South San Francisco, California
job type: Contract
salary: $80 - 90 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
As a key member of the Study Team, you will drive PV operational activities from study start-up to close-out, including:
- Reviewing safety management plans and protocol safety reporting language
- Overseeing study-specific safety database configuration
- Managing PV record keeping and database lock coordination
- Engaging with multiple PV vendors to ensure alignment with strategic KPIs
- Oversee safety operational content and processes for clinical trials, including protocols, CRFs, safety management plans, SAE and pregnancy forms.
- Manage safety database requirements and configurations, ensuring seamless safety-related activities throughout studies.
- Develop training materials and processes for clinical trial safety report collection.
- Review and archive PV records in documentation management systems (e.g., TMF).
- Support clinical trial safety report collection, collaborating cross-functionally (e.g., Clinical Operations, Data Management, Regulatory, Biostatistics).
- Oversee PV vendor performance, monitor compliance, and implement corrective and preventive actions.
- Act as a subject matter expert in audits/inspections, leading PV vendor readiness efforts.
- Identify gaps and improvement areas within the PV system and drive strategic initiatives.
- Develop, maintain, and implement PV procedural documents (e.g., SOPs).
- Contribute to business alliance management and establish a PV business continuity plan.
qualifications:
- Bachelor's degree in biological/natural sciences or healthcare discipline (e.g., nursing, pharmacy); Advanced degree (Ph.D., MPH, NP, PharmD) preferred.
- 5+ years of pharmacovigilance and GCP experience required.
- Strong understanding of global safety reporting regulations (FDA, ICH, EU) and case processing for ICSRs, including submissions.
- Experience in vendor oversight and KPI monitoring.
- Excellent organizational and project management skills with the ability to prioritize complex tasks.
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
- Solid knowledge of medical/clinical practices, medical concepts, and terminology.
- Proven ability to work independently and proactively with minimal supervision.
skills: Pharmacovigilance, Vendor Management, GCP (Good Clinical Practice), Argus, Drug Safety, ICH Regulations, AD (Adverse Events), ICSR (Individual Case Study Report)
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 health, an incentive and recognition program, and 401K contribution (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.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
