Senior Director Pharmacovigilance Job at Meet Life Sciences, San Jose, CA

N3hNSzNaWU4yZ1FQTXVlcWJ6aEx4MmQ4c0E9PQ==
  • Meet Life Sciences
  • San Jose, CA

Job Description

Senior Director of Pharmacovigilance (PV) – Summary:

Company Overview:

  • Clinical-stage biopharmaceutical company focused on rare diseases.
  • Located in the San Francisco Bay Area, CA.

Key Responsibilities:

  • Evaluate and assess adverse event (AE) reports for safety issues.
  • Manage PV vendors and ensure compliance.
  • Act as Subject Matter Expert (SME) for Individual Case Safety Report (ICSR) processing.
  • Ensure AE reporting complies with global regulations (FDA, EMA, ICH).
  • Update and create SOPs; lead process improvement initiatives.
  • Collaborate with departments and partners on drug safety data exchange.
  • Lead training on AE and product complaints for internal teams and vendors.

Qualifications:

  • Education: Bachelor’s in science/health-related field; advanced degrees are a plus.
  • Experience: 10+ years in Pharmacovigilance, Drug Safety, or Risk Management.
  • Knowledge: Strong understanding of global PV regulations (e.g., US CFR, EMA, ICH).
  • Technical Skills: Proficiency with safety databases (e.g., Oracle Argus, ArisGlobal).
  • Communication: Strong cross-functional collaboration, leadership, and interpersonal skills.

Ideal Candidate:

  • Extensive experience in PV, with expertise in global regulations and safety databases.
  • Strong leadership and ability to drive process improvements.

Job Tags

Similar Jobs

Kazi

Junior Account Sales Job at Kazi

 ...solutions that make it easy for customers to buy our clients services. As an important part of the sales and business development team, Entry Level Junior Account Executives are responsible for initiating and developing strong relationships with our customers. The ideal... 

Minnesota Department of Transportation

CADD Student Worker Technician Job at Minnesota Department of Transportation

 ...work full-time during the summer and part-time during the school year, based on students' availability and the needs of the department....  ...instructions. Valid Class D Drivers License. Must be 18 years old or older. APPLY ONLINE BY 4/15/2025: # Go to # Click ... 

Iv Ymca

Rock Steady Boxing Coach/Volunteer Job at Iv Ymca

POSITION: COACH & VOLUNTEERSWe are in need of Rock Steady Coaches. We also need Volunteers to assist the Coaches. A Coach should have...  ...s disease to fight their disease by providing non-contact boxing style fitness programs that improve their quality of life and... 

Coda Search│Staffing

Legal Intake Specialist Job at Coda Search│Staffing

 ...The ideal candidate must possess the following attributes: Customer Service Experience Professional and empathetic telephone etiquette Active listening, verbal and communication skills Computer proficiency (Microsoft Office 365/Suite) Excellent... 

Deep Clean Texas

House Cleaner/Housekeeper (Full Time) - Weekly Pay Job at Deep Clean Texas

House Cleaner/Housekeeper (Full Time) - Weekly Pay Location Montgomery, TX : Do you LOVE Cleaning? Our Employees LOVE What They Do! Top Pay, Great Benefits. ***ALL CANDIDATES PLEASE NOTE: YOU WILL ONLY BE CONSIDERED IF YOU COMPLETE THE APPLICATION, THE PHONE SCREENING,...