Oncology Medical Safety Lead

Parexel; United States; Remote; USD 180.000 - 230.000; Vollzeit

Zusammenfassung

Parexel seeks an Associate Medical Safety Director to lead oncology pharmacovigilance initiatives across client portfolios and drive risk management improvements. You will combine clinical leadership with scientific expertise to ensure patient safety and regulatory compliance.

You’ll collaborate with cross-functional teams, guide safety governance, and contribute to high-priority oncology projects in a dynamic, client-focused environment.

Qualifikationen

• Oncology expertise with clinical or pharmacovigilance background.
• Proven signal detection, evaluation and management experience.
• Leadership in drug safety with global regulatory know-how (ICH GCP, GVP).
• Strong medical judgment and ability to work cross-functionally.

Aufgaben

• Lead medical safety initiatives across oncology portfolio with scientific rigor.
• Oversee safety deliverables and aggregate safety reports (PBRERs/DSURs).
• Represent the safety function in client meetings, audits and inspections.
• Mentor colleagues in signal detection methodologies and governance.
• Support regulatory submissions and ongoing safety monitoring activities.

Kenntnisse

Oncology expertise

Signal management

Pharmacovigilance leadership

Clinical excellence

Client-facing

Ausbildung

Medical Degree (MBBS/MD)

Clinical training (residency/internship)

Regulatory knowledge in global safety

Jobbeschreibung

Parexel seeks an Associate Medical Safety Director to lead oncology pharmacovigilance initiatives across client portfolios and drive risk management improvements. You will combine clinical leadership with scientific expertise to ensure patient safety and regulatory compliance.

You’ll collaborate with cross-functional teams, guide safety governance, and contribute to high-priority oncology projects in a dynamic, client-focused environment.