Senior Pharmacovigilance Specialist, Safety Data Management
Alvotech
Not specified (assumed hybrid)
Icsr/sae management
Regulatory submissions
Safety systems lifecycle management
Alvotech is seeking a Senior Pharmacovigilance Specialist to join their Global Safety Data Management team. The role involves overseeing clinical safety and post-marketing pharmacovigilance activities, with a strong emphasis on regulatory compliance and process optimization
Job Summary
The Senior Pharmacovigilance Specialist will be responsible and accountable for all assigned Clinical Safety and post-marketing PV activities within the newly developed, lean and efficient, Global Safety Data Management team.
The role involves working independently, owning assigned activities, and ensuring regulatory compliance through the development, maintenance, and optimization of Global Pharmacovigilance processes.
Responsibilities include managing safety data for clinical trials and post-marketing programs, participating in safety systems setup and lifecycle management, and collaborating cross-functionally with various internal and external teams.
Matching Summary
Match Score: 85
Alvotech is seeking a Senior Pharmacovigilance Specialist to join their Global Safety Data Management team. The role involves overseeing clinical safety and post-marketing pharmacovigilance activities, with a strong emphasis on regulatory compliance and process optimization.
Skills & Requirements
Must-have
ICSR/SAE management
Regulatory submissions
Safety systems lifecycle management
Global Pharmacovigilance processes
Clinical trial safety
Post-marketing PV activities
Nice-to-have
Result oriented work environment
Multicultural team comfort
Biologic and combination products experience
Key Requirements
Master’s Degree in pharmaceutical sciences or related fields
5+ years in Pharmacovigilance/Drug Safety
Expertise in Safety systems (e.g., Argus, ARISg)
Proven track record working with global Products and Clinical trials
Detailed knowledge of PV processes, directives, regulations and international guidelines