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 contribute to pharmacovigilance and risk-management strategies.
- Participate in cross-functional safety governance and Safety Review Teams.
- Recommend appropriate characterization, management, and communication of identified safety risks.
- Provide safety input into clinical study protocols, product labeling, and other clinical-development activities.
- Partner with Clinical Development, Regulatory Affairs, Medical Affairs, and other cross-functional stakeholders.
- Recognize and appropriately escalate significant safety issues to senior leadership and safety governance.
- Support regulatory inspections and inspection-readiness activities.
Required 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.
Preferred Qualifications:- 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. 
