Vice President, Global Drug Safety & Pharmacovigilance

Alpha Clinical Laboratory Inc; San Francisco (CA); Hybrid; USD 250,000 - 350,000; Full time

Job summary

Alpha Clinical Laboratory Inc seeks an experienced Head of Drug Safety & Pharmacovigilance to lead global PV strategy for a biologics portfolio in the San Francisco Bay Area. The role requires hands-on oversight of safety operations, signal detection, and regulatory submissions across oncology, metabolic, and immunology assets.

You will lead a cross-functional team, drive compliance with global PV regulations, and partner with Clinical Development, Regulatory Affairs, and CROs to scale PV

Qualifications

• MD/PhD/PharmD in life sciences or equivalent.
• 10+ years in drug safety/pharmacovigilance.
• 5+ years in biopharmaceutical leadership.
• Strong oncology safety experience with complex profiles.
• Experience with clinical safety and regulatory submissions (US/EU).
• Proficient in safety databases and governance.

Responsibilities

• Define global PV strategies across oncology, metabolic, immunology.
• Oversee PV activities across I-III trials and reporting (DSURs, PSURs).
• Lead signal detection, risk mitigation, and benefit-risk assessments.
• Manage safety sections for INDs/NDAs and regulator queries.
• Ensure compliance with 21 CFR Part 312, ICH E2, GVP.
• Represent PV in regulatory audits and inspections readiness.
• Oversee safety review processes and DSMB coordination.
• Collaborate cross-functionally with Clinical, Regulatory, Biostatistics, Medical Affairs.
• Mentor PV team and scale global safety operations.

Skills

Leadership

Oncology safety experience

Regulatory submissions experience

Cross-functional collaboration

Communication skills

Time-zone coordination

Education

MD/PhD/PharmD in Life Sciences

Tools

Argus/ArisG/Oracle safety databases

Job description

Alpha Clinical Laboratory Inc seeks an experienced Head of Drug Safety & Pharmacovigilance to lead global PV strategy for a biologics portfolio in the San Francisco Bay Area. The role requires hands-on oversight of safety operations, signal detection, and regulatory submissions across oncology, metabolic, and immunology assets.

You will lead a cross-functional team, drive compliance with global PV regulations, and partner with Clinical Development, Regulatory Affairs, and CROs to scale PV