SERM Scientific Director
Core
Leads pharmacovigilance and risk management planning, safety evaluation, and global regulatory submissions for GSK's clinical and post-marketing assets.
Role type
Senior IC Scientific Director (Pharmacovigilance)
Builds
Safety strategies and risk-reduction plans for global pharmaceutical assets
Domain
Biopharmaceuticals / Pharmacovigilance
Deliverable
client delivery
Required skills
Pharmacovigilance, Signal Detection, Safety Evaluation, Risk Management, Clinical Data Synthesis, Regulatory Submissions, International PV Requirements (ICH/GVP/CIOMS), Matrix Organization Leadership
Preferred skills
Team Lead Management, Enterprise Leadership, Presentation Techniques
Technologies
None stated
Responsibilities
Leads Pharmacovigilance and Risk Management Planning; Leads safety component of global regulatory submissions; Leads safety governance and SRTs; Represents GSK in cross-functional Clinical Matrix Teams; Authors/participates in standard updates (SOPs); Accounts for escalation of safety issues to senior governance; Leads inspection readiness and audit support.
Seniority
Senior, hands-on IC with management experience