Senior Director Pharmacovigilance Job at Meet Life Sciences, Sonoma, CA

eE9PdVAzbkFkZmZ1ZzFPYlNzWmY3SjRXb3c9PQ==
  • Meet Life Sciences
  • Sonoma, 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

Enterprise Medical Recruiting

Internal Medicine Physician Opening in Southwest Connecticut Job at Enterprise Medical Recruiting

 ...A thriving non-profit multispecialty group in southwest Connecticut has an opening for an Internal Medicine Physician to join a team of 5 Physicians. About the Opportunity: ~100% outpatient ~ No night or weekend office hours ~36 patient contact hours ~ Call... 

Korean Women's Association

LONGVIEW Personal Care Assistant - Caregiver, Home Care Aide, Home Health Aide, Nursing Assistant, Personal Care Aide, CNA, RNA, HCA, Respite Care worker Job at Korean Women's Association

 ...Silverlake, Ariel, Toutle, Cowlitz County, City of Trees, homecare, healthcare, in home care, CNA, HCA, RNA, certified nursing assistant, home care aide, registered nursing assistance, nursing aide, healthcare aide, caregiver, personal care assistant, respite caregiver,... 

Sheldon Meadows Assisted Living Center

Housekeeping and Laundry Assistant Job at Sheldon Meadows Assisted Living Center

 ...directions provided in English. Maturity and ability to deal effectively with the demands of the job. Experience in health care of hotel housekeeping or laundry is preferred, but not essential.Must be able to pass the state mandated criminal background screening and... 

Stand-By Personnel

Welding Engineer Job at Stand-By Personnel

 ...Job Title: Welding Engineer Hours: 7:00 AM 4:30 PM | MondayFriday Pay: $28.00+/hr (Based on experience) Location: Tulsa, OK Job Order #: 122966 Position Overview Were hiring a knowledgeable and driven Welding Engineer to support automotive... 

Girl Scouts San Diego

Day Camp Teen Leadership Coordinator Job at Girl Scouts San Diego

 ...As a Teen Leadership Coordinator , you will develop and deliver a training program for Day Camp Aides (DCA), counselors-in-training...  ...evaluate DCAs/CITs, giving guidance and feedback. Serve as a role model to DCAs/CITs and other staff of appropriate counselor behavior....