Associate Medical Director Pharmacovigilance & Clinical Safety

Associate Medical Director - Pharmacovigilance & Clinical Safety

Location: Remote - United States to be eligible must be located in the following states: CO, CT, DE, FL, GA, IL, MA, MD, MO, NC, NE, NJ, NY, NV, PA, SC, TN, TX, VA, WVA.

Employment Type: Full-Time, Fully Benefited

Assignment Duration: Initial 12-month engagement, with potential extension

Compensation: Approximately $91.35-$112.98/hour W-2, with benefits

Employment Eligibility & Application Requirements

• No third-party agencies or vendors: Alphanumeric Systems is accepting applications from individual candidates only. Submissions from staffing agencies, third-party recruiters, consulting firms, or subcontractors will not be considered.
• Work Authorization: Candidates must be legally authorized to work in the United States without employer sponsorship, now or in the future. Alphanumeric Systems is unable to provide employment-based visa sponsorship or visa transfers for this position.
• Employment Classification: This is a direct W-2 employment opportunity with Alphanumeric Systems, including employee benefits. C2C and 1099 arrangements are not available.

About the Opportunity

Alphanumeric Systems is seeking an experienced Associate Medical Director - Pharmacovigilance & Clinical Safety to support the Global Safety organization of a leading pharmaceutical company.

This position provides medical and scientific expertise in the evaluation, interpretation, and management of pharmaceutical safety information throughout clinical development and the post-marketing product lifecycle.

As part of the Safety Evaluation and Risk Management (SERM) function, you will work alongside Medical Directors, Scientific Directors, and cross-functional safety teams to evaluate emerging safety concerns, contribute to benefit-risk assessments, support regulatory submissions, and develop evidence-based medical safety recommendations.

The ideal candidate brings a strong medical background, substantial pharmacovigilance or clinical drug development experience, and the ability to translate complex clinical and safety data into scientifically sound assessments and regulatory communication

What You''ll Do

• Provide medical and scientific expertise in the evaluation of safety data from clinical trials, post-marketing surveillance, medical literature, and other relevant sources.
• Participate in signal detection, signal evaluation, and the characterization of emerging or potential product safety risks.
• Conduct medically informed assessments of adverse events, safety trends, and potential risks associated with investigational and marketed pharmaceutical products.
• Contribute to benefit-risk evaluations and develop recommendations for safety monitoring, risk mitigation, and risk communication.
• Author or contribute to medical and scientific safety content for global regulatory submissions and Health Authority inquiries.
• Support the preparation and review of aggregate safety documentation, including DSURs, PSURs/PBRERs, Risk Management Plans (RMPs), and related reports.
• Collaborate with product physicians, safety scientists, and Regulatory Affairs colleagues to develop scientifically sound responses to regulatory safety questions.
• Participate in Safety Review Teams and cross-functional safety governance discussions, presenting medical safety assessments and recommendations to senior stakeholders.
• Evaluate potential implications of emerging safety information for clinical protocols, investigator brochures, product labeling, and risk-management activities.
• Identify and escalate significant safety concerns to appropriate medical leadership and safety governance bodies.
• Work collaboratively with Clinical Development, Medical Affairs, Regulatory Affairs, Biostatistics, and Pharmacovigilance colleagues.
• Contribute to pharmacovigilance process improvements, regulatory compliance, and quality initiatives.