Global Medical Safety Director — Remote/Hybrid

Pharming Group; New Jersey; Hybrid; USD 240,000 - 280,000; Full time

Benefits offered by this job

Annual target bonus

Long-term incentive program

401(k) plan with company match

Paid Time Off

13 Company Holidays

Health and wellness program

Phone stipend

Job summary

Pharming is seeking a medical safety leader to oversee global pharmacovigilance activities, including risk assessment, signal management, and regulatory responses. The role involves medical review of CSIs and collaboration with Clinical Operations, Medical, and Regulatory teams, with travel to NJ and potential remote work options.

Ideal candidates hold an MD/DO or equivalent, with at least six years in PV. Board certification preferred.

Qualifications

• MD, DO, or equivalent medical degree required.
• Minimum six years of industry PV and drug safety experience.
• Board certification and completed residency strongly preferred.
• Strong interpersonal skills and ability to collaborate across departments.
• Deep understanding of 21CFR, GVP modules and ICH guidelines.
• Ability to travel domestically and internationally (approx. 10%).

Responsibilities

• Identify, evaluate, manage and escalate safety risks for Pharming products.
• Lead benefit-risk assessments and signal management activities.
• Provide medical input for PSUR/DSUR and other reports.
• Answer regulatory authority inquiries and support inspections/audits.
• Mentor and coach EU-based team members and safety governance bodies.
• Ensure compliance with PV regulations and company procedures.

Skills

PV risk management

Regulatory interaction

I CSR review

Safety signal detection

Medical review

Leadership

Education

MD/DO or equivalent

Board certification (preferred)

Residency training in clinical specialty

Job description

Pharming is seeking a medical safety leader to oversee global pharmacovigilance activities, including risk assessment, signal management, and regulatory responses. The role involves medical review of CSIs and collaboration with Clinical Operations, Medical, and Regulatory teams, with travel to NJ and potential remote work options.

Ideal candidates hold an MD/DO or equivalent, with at least six years in PV. Board certification preferred.