Biotech Pharmacovigilance Operations Manager

Allogene Therapeutics; South San Francisco (CA); Hybrid; USD 140,000 - 150,000; Full time

Benefits offered by this job

Annual bonus

Equity compensation

Health insurance

Generous paid time off

Holiday shutdowns

Job summary

Allogene Therapeutics in South San Francisco, CA, seeks a Manager, Pharmacovigilance Operations to lead safety operations across studies and vendor management. You will oversee DSURs and regulatory reporting while collaborating with cross-functional teams.

The role may be remote with travel to the South San Francisco HQ or hybrid onsite three days a week. The ideal candidate has 5+ years in pharmacovigilance, strong communication, and proficiency with safety databases such as Argus and ARISg.

Qualifications

• Bachelor’s degree in life sciences or related discipline; advanced degree preferred.
• Minimum 5 years pharmacovigilance experience in pharma/biotech.
• Strong knowledge of US and ex-US PV regulatory requirements (ICH, EU GVP).
• Proficiency with safety databases and systems (Argus, ARISg, MedDRA, WHODrug, SPEED).
• Excellent organizational skills and ability to prioritize and deliver on timelines.
• Ability to work independently and collaboratively in a fast-paced environment.

Responsibilities

• Assist in Safety Vendor Oversight activities including KPI tracking and compliance metrics.
• Participate in eTMF filing for Allogene studies per TMF plans and procedures.
• Schedule PV team meetings and manage agendas; support Study Management as needed.
• Facilitate preparation and submission of periodic safety reports (DSUR, 6M LL) and regulatory filings.
• Assist in MedDRA and WHODrug coding as needed.
• Collaborate on safety sections in Investigator Brochures, RSI, DSURs, Protocols, and ICFs.
• Manage Regulatory Reporting Requirements across all studies to meet regulations.
• Support cross-functional projects and cross-department initiatives.
• Liaise with QA for CAPA activities related to PV processes and SMPs.
• Maintain SUSAR tracker and perform monthly reconciliations.
• Participate in regulatory inspections and PV audits.

Skills

Organizational skills

Independent & collaborative work

Interpersonal communication

Education

Bachelor’s degree in life sciences or related discipline

Advanced degree (RN/BSN/PharmD) preferred

Tools

Oracle Argus

ARISg

MedDRA

WHODrug

SPEED

Job description

Allogene Therapeutics in South San Francisco, CA, seeks a Manager, Pharmacovigilance Operations to lead safety operations across studies and vendor management. You will oversee DSURs and regulatory reporting while collaborating with cross-functional teams.

The role may be remote with travel to the South San Francisco HQ or hybrid onsite three days a week. The ideal candidate has 5+ years in pharmacovigilance, strong communication, and proficiency with safety databases such as Argus and ARISg.