Remote Director, Pharmacovigilance & Clinical Safety

Alphanumeric Systems Inc; Durham (NC); Remote; USD 200,000 - 250,000; Full time

Job summary

Alphanumeric Systems seeks an experienced Scientific Director - Pharmacovigilance & Clinical Safety to support the Global Safety organization of a leading pharmaceutical company. This senior role focuses on safety evaluation across clinical development and post-marketing.

The Director will evaluate complex safety data, respond to Health Authority RFIs, contribute to regulatory submissions, and shape risk-management strategies while collaborating with Clinical Development, Regulatory Affairs, and

Qualifications

• Degree in a Health Sciences or Healthcare Professional discipline.
• Extensive pharma/biotech experience in Pharmacovigilance or Drug Safety.
• Experience in safety evaluation and risk management for clinical-development and post-marketing products.
• Experience supporting Health Authority RFIs with scientific responses.
• Strong understanding of clinical development and drug approval processes.
• Knowledge of ICH, GVP, and CIOMS.
• Ability to work independently within a global matrix organization.
• Strong scientific writing and cross-functional collaboration.

Responsibilities

• Provide in-depth scientific expertise in pharmacovigilance, clinical safety and risk management.
• Evaluate and interpret safety data from clinical development and post-marketing.
• Assess emerging safety issues and contribute to benefit-risk evaluations.
• Author scientifically sound responses to Health Authority RFIs.
• Lead or support safety components of global regulatory submissions.
• Develop pharmacovigilance strategies and risk-management plans.
• Participate in Safety Review Teams and cross-functional governance.
• Communicate safety risks to senior leadership and safety governance.
• Support regulatory inspections readiness.

Skills

Scientific writing

Verbal communication

Cross-functional collaboration

Independent work

Risk management

Safety governance

Clinical development understanding

Regulatory RFIs handling

Education

Degree in Health Sciences or Healthcare

Advanced degree (PhD/MD etc.)

Job description

Alphanumeric Systems seeks an experienced Scientific Director - Pharmacovigilance & Clinical Safety to support the Global Safety organization of a leading pharmaceutical company. This senior role focuses on safety evaluation across clinical development and post-marketing.

The Director will evaluate complex safety data, respond to Health Authority RFIs, contribute to regulatory submissions, and shape risk-management strategies while collaborating with Clinical Development, Regulatory Affairs, and