Associate Scientific Director Pharmacovigilance & Clinical Safety

Associate Scientific 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 $79.33-$96.15/hour W-2

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 Scientific Director - Pharmacovigilance & Clinical Safety to support the Global Safety organization of a leading pharmaceutical company.

This position focuses on Safety Evaluation and Risk Management (SERM) across clinical development and post-marketing activities. The successful candidate will provide scientific expertise in evaluating emerging safety signals, interpreting complex clinical and safety data, contributing to benefit-risk assessments, and developing scientifically sound safety recommendations.

Working closely with Medical Directors, Scientific Directors, regulatory professionals, and cross-functional safety teams, you will contribute to product safety strategy, Health Authority responses, regulatory submissions, and safety governance activities.

This is an excellent opportunity for an experienced Safety Scientist or Pharmacovigilance professional who enjoys hands-on scientific analysis and wants to contribute to global patient safety.

What You''ll Do

• Perform signal detection, evaluation, and ongoing safety surveillance for assigned pharmaceutical products across clinical development and post-marketing settings.
• Analyze and interpret clinical trial data, post-marketing safety information, medical literature, and other relevant sources to identify and characterize potential safety risks.
• Develop scientifically supported safety assessments, benefit-risk evaluations, and recommendations for risk characterization, mitigation, and communication.
• Author or contribute to the safety components of global regulatory submissions, including responses to Health Authority inquiries.
• Support the development and review of periodic safety reports, including DSURs, PSURs/PBRERs, Risk Management Plans (RMPs), and related safety documentation.
• Collaborate with product physicians and cross-functional teams to ensure accurate and timely regulatory safety reporting.
• Participate in Safety Review Teams and safety governance activities, including presenting complex safety findings and recommendations to senior stakeholders.
• Support the evaluation and implementation of risk-reduction measures in clinical study protocols, product labeling, and other safety communications.
• Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, and Pharmacovigilance colleagues to address emerging safety issues.
• Contribute to process improvements, regulatory compliance, and pharmacovigilance quality initiatives.
• Provide scientific guidance and support to colleagues within a global matrix environment.