[Hiring] Medical Director of Pharmacovigilance & Clinical Safety @Alphanumeric Systems

Role Description

Alphanumeric Systems is seeking an experienced Medical Director - Pharmacovigilance & Clinical Safety to support the Global Safety organization of a leading global pharmaceutical company. This senior-level role supports a Safety Evaluation and Risk Management function responsible for the medical and scientific evaluation of safety information across products in clinical development and the post-marketing setting.

• Evaluate complex clinical and safety data.
• Assess emerging safety issues.
• Support benefit-risk and risk-management activities.
• Contribute to global regulatory submissions and safety governance.
• Respond to Health Authority Requests for Information (RFIs) or similar regulatory queries.
• Independently analyze clinical and safety information.
• Author scientifically sound medical or safety responses to Health Authorities such as the FDA, EMA, PMDA, or comparable regulatory agencies.

Qualifications

• Medical/clinical doctorate required.
• MD/DO/MBBS preferred; DVM, DDS/DMD, or equivalent clinical doctorate may be considered for candidates with significant relevant pharmacovigilance experience.
• Extensive pharmaceutical or biotechnology industry experience in Pharmacovigilance, Drug Safety, Clinical Safety, Medical Affairs, or a closely related area.
• Significant experience in safety evaluation and risk management involving clinical-development and/or post-marketing products.
• Direct experience supporting Health Authority RFIs or regulatory queries, including independently authoring medical/scientific responses or substantive portions of responses.
• Strong understanding of clinical development and drug approval processes.
• Knowledge of international pharmacovigilance requirements and standards, including ICH, GVP, and CIOMS.
• Demonstrated ability to synthesize complex clinical and safety information and develop scientifically defensible conclusions.
• Ability to work independently while recognizing when safety issues require escalation.
• Strong written, verbal, and cross-functional communication skills.

Requirements

• Oncology clinical-development and/or oncology safety experience.
• Experience supporting interactions with FDA, EMA, PMDA, or other major Health Authorities.
• Experience with safety governance, signal evaluation, benefit-risk assessment, and risk-management planning.
• Experience supporting global pharmaceutical development programs.
• Candidates must be authorized to work in the United States. Sponsorship is not available for this position.
• Applications or candidate submissions from third-party staffing agencies/vendors will not be considered.