Sr. Pharmacovigilance (PV) Clinical Scientist

The Fountain Group LLC

South San Francisco, CA

JOB DETAILS
SALARY
$41.07–$62.94 Per Hour
SKILLS
Adverse Events, Biotech and Pharmaceutical, Clinical Assessment, Clinical Research, Clinical Support, Cross-Functional, Database Administration, FDA Requirements, Government Funding, Healthcare, ICH Regulations, Maintain Compliance, Medical Products, Medical and Scientific Writing, Metrics, Patient Safety, Pharmacovigilance, Presentation/Verbal Skills, Process Development, Process Improvement, Project/Program Management, Quality Management, Quality Monitoring, Reconciliation, Registered Nurse (RN), Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Safety Compliance, Safety Systems, Safety Training, Standard Operating Procedures (SOP), Time Management, Training/Teaching, Trend Analysis
LOCATION
South San Francisco, CA
POSTED
3 days ago

The Fountain Group is currently seeking a Sr. Pharmacovigilance (PV) Clinical Scientistr for a prominent client of ours. This position is located at South San Francisco, CA. Details for the position are as follows:

Sr. Pharmacovigilance (PV) Clinical Scientist
Location: South San Francisco, CA (Hybrid)
Pay Rate: $41.07–$62.94/hr
Shift: 8:00 AM – 4:30 PM PT
Duration: 6 Months (High Possibility of Extension)

Job Description

Seeking a Sr. Pharmacovigilance Clinical Scientist to support pharmacovigilance compliance activities within the US Patient Safety organization. This role is responsible for the clinical review, evaluation, processing, and quality oversight of adverse event reports and Individual Case Safety Reports (ICSRs), while ensuring compliance with global safety regulations and internal procedures. The position serves as a subject matter expert for safety operations, vendor oversight, process improvements, and regulatory compliance initiatives.

  • Perform clinical review, evaluation, and processing of adverse event reports and Individual Case Safety Reports (ICSRs)
  • Conduct case triage, medical assessment, seriousness, validity, causality, and labeling evaluations
  • Ensure timely and compliant case processing within the global safety database
  • Lead quality review activities for in-house and vendor-processed safety cases
  • Monitor ICSR quality trends, perform trend analyses, and escalate compliance risks as needed
  • Develop executive summaries and metrics related to pharmacovigilance quality and compliance
  • Support Health Authority submissions and ensure adherence to local and global regulatory requirements
  • Manage follow-up activities, correspondence workflows, and data corrections within safety systems
  • Identify process gaps and lead SOP updates, process improvements, and training initiatives
  • Support adverse event reconciliation, Case Transmission Verification (CTV), and safety data exchange activities
  • Collaborate with internal teams, vendors, and regulatory stakeholders on pharmacovigilance operations
  • Provide support during audits, inspections, and regulatory assessments
  • Develop and deliver patient safety presentations and training materials

Education

  • Healthcare professional degree required, including RN, BSN, MSN, NP, RPh, B.Pharm, PharmD, MD, or equivalent
  • Minimum 5–7 years of pharmacovigilance experience within the biopharmaceutical industry or equivalent clinical experience

Required Skills

  • Pharmacovigilance operations
  • Individual Case Safety Report (ICSR) processing
  • Adverse event (AE) management
  • Clinical review and medical assessment
  • Case triage, seriousness, validity, and causality assessment
  • Safety database management
  • Health Authority submissions
  • FDA safety regulations
  • ICH guidelines
  • EMA regulations
  • Global pharmacovigilance compliance
  • Safety data reconciliation
  • Case Transmission Verification (CTV)
  • Vendor oversight and compliance management
  • SOP authoring and process improvement
  • Medical and scientific writing
  • Technical Product Complaints (TPC)
  • Medical Product Complaints (MPC)
  • Safety trend analysis and risk assessment
  • Training development and delivery
  • Audit and inspection support
  • Project management

Preferred Skills

  • Experience with global safety databases
  • Government-sponsored pharmacovigilance programs
  • Cross-functional safety data exchange
  • Pharmacovigilance quality management
  • Regulatory impact assessments
  • Subject matter expertise in safety compliance operations
  • Executive presentation development
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About the Company

T

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/