Medical Director of Pharmacovigilance & Clinical Safety

Medical Director - Pharmacovigilance & Clinical Safety.

Location: Remote - United States.Schedule: Monday - Friday, 9:00 AM - 5:00 PM Eastern Time.Employment Type: Full-time, fully benefited position with Alphanumeric Systems.Salary Range: $250,000-$300,000 annually, based on experience and qualifications. Position Overview: 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.

The Medical Director will evaluate complex clinical and safety data, assess emerging safety issues, support benefit-risk and risk-management activities, and contribute to global regulatory submissions and safety governance.

A critical requirement is experience responding to Health Authority Requests for Information (RFIs) or similar regulatory queries. Candidates must have experience independently analyzing clinical and safety information and authoring scientifically sound medical or safety responses, or substantive portions of responses, to Health Authorities such as the FDA, EMA, PMDA, or comparable regulatory agencies. Key Responsibilities:* Provide in-depth medical and scientific expertise in pharmacovigilance, clinical safety, safety evaluation, and risk management. * Evaluate and interpret clinical-development and post-marketing safety data. * Assess emerging safety issues and contribute to ongoing benefit-risk evaluation for assigned products. * Independently author scientifically sound responses to Health Authority RFIs and regulatory safety queries. * Lead or support safety components of global regulatory submissions. * Develop and contrib