Sr. Principal Scientist (Sr. Director) , Drug Safety
Core
End-to-end process owner for Drug Safety (CSRM) processes, ensuring regulatory compliance, safety surveillance, and risk management for assigned products.
Role type
Sr. Principal Scientist (Sr. Director), Drug Safety
Builds
Compliant end-to-end pharmacovigilance and risk management processes
Domain
Pharmaceutical industry, Drug Safety, Pharmacovigilance
Required skills
Pharmacovigilance, Risk Management, Regulatory Compliance Audits, Safety Databases, Clinical Judgment, Drug Safety Surveillance, Global Program Development, Adverse Event Report, Cross-Functional Teamwork
Preferred skills
Master's in nursing/PharmD/PA, 10-12 years clinical/pharma experience, 5+ years safety experience, PASS/PSMP/ARMM knowledge, QPPV interface experience
Technologies
Safety Databases, PSMF
Responsibilities
Oversee development and maintenance of departmental SOPs and execution resources; Evaluate emerging regulations and integrate changes; Provide expert consultation on pharmacovigilance and risk management; Lead engagement with auditors, inspectors, and regulators; Develop strategies for regulatory documents and safety inquiries; Support IPV in assessing local regulatory considerations; Partner with QPPV office for PSMF oversight.
Seniority
Sr. Principal Scientist (Sr. Director), Strategy & Mentorship