Associate Medical Safety Director – Sponsor Dedicated (Remote)

About the role

The Associate Medical Safety Director will support the Lifecycle Safety Medical team by providing pharmacovigilance and risk‑management expertise for assigned product portfolios. This remote position involves medical evaluation of adverse events, signal detection, and contribution to regulatory submissions.

Key responsibilities

• Provide aggregate safety reviews and maintain oversight of product safety profiles.
• Lead signal detection strategy, review reports, raise potential signals, and contribute to safety analysis presentations.
• Review and contribute to IND Annual Reports, EU Periodic Benefit‑Risk Evaluation Reports, US Periodic Reports, and related regulatory documents.
• Support development of Risk Management Plans, EU Risk Management Plans, and US REMS.
• Perform medical review of trial‑related adverse events and post‑marketing ADRs, including narrative, coding, causality, and seriousness assessments.
• Represent safety findings in internal and external stakeholder meetings and attend Safety Governance meetings as needed.

Required profile

• Medical degree from an accredited, internationally recognized medical school.
• Approximately three years of clinical practice plus two years in the pharmaceutical or related industry, or an equivalent combination of education and experience.
• Knowledge of federal and local regulations governing clinical research, safety, and good clinical practice.
• Familiarity with the assigned therapeutic area, product portfolio, and recent scientific literature.

Required skills

• Experience in signal detection, aggregate reporting, and risk management.
• Ability to synthesize data from multiple sources and communicate complex clinical issues both orally and in writing.
• Strong organizational skills to meet priorities, deadlines, and objectives under pressure.
• Capability to build effective working relationships with colleagues, managers, and external partners.