Global Head, Pharmacovigilance & Risk Management (Remote)

Exelixis; United States; Remote; USD 399,000 - 504,000; Full time

Benefits offered by this job

401k plan with generous company0conb

Group medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

Flexible spending accounts

Discretionary annual bonus program

Sales-based incentive plan (if field)

Opportunity to purchase company stock

Long-term incentives

Paid vacation days

Paid holidays

Sick days

Job summary

Exelixis seeks an Executive Medical Director, PVRM to lead the global product safety strategy for complex programs and post‑marketing pharmacovigilance activities. You will mentor teams, manage safety deliverables, and collaborate across functions to execute the corporate development strategy.

You will oversee safety data analyses, risk management planning, and communications with Health Authorities, DMSBs, and investigators, while guiding core safety documentation and lifecycle evaluations.

Qualifications

• MD degree with 10+ years post-residency experience or equivalent.
• 3+ years clinical experience post-residency.
• 10+ years pharmacovigilance or related pharma/biotech experience.
• Oncology pharmacovigilance experience is a plus.

Responsibilities

• Lead safety strategy for complex clinical programs and post‑marketing pharmacovigilance.
• Develop safety data analysis strategies across clinical studies.
• Interpret safety analyses and present data to Health Authorities/DSMBs/Investigators.
• Establish safety deliverables strategy including signals, aggregate reports, risk management.
• Lead cross-functional Benefit-Risk Team and escalate to the BR Exec Committee.
• Develop core safety documents and safety evaluations for lifecycle.
• Lead proactive safety reviews and monitor risk management effectiveness.

Skills

Safety leadership

Strategic planning

Cross-functional collaboration

Pharmacovigilance experience

Data analysis

Regulatory knowledge

Education

MD degree

Board Certification preferred (US)

Job description

Exelixis seeks an Executive Medical Director, PVRM to lead the global product safety strategy for complex programs and post‑marketing pharmacovigilance activities. You will mentor teams, manage safety deliverables, and collaborate across functions to execute the corporate development strategy.

You will oversee safety data analyses, risk management planning, and communications with Health Authorities, DMSBs, and investigators, while guiding core safety documentation and lifecycle evaluations.