Clinical Safety Specialist

ROLE DESCRIPTION:

• Executes various project tasks within and beyond the Clinical Safety Unit, covering Global ICSR processing, Literature monitoring, Signal Management, Benefit Risk Management, XEVMPD Medicinal Product Management, Local project management, Regulatory Intelligence, report preparation, Risk Management Plans, study protocols, product documentation, and PV contract management.
• Handles other project-specific tasks as needed. • Escalates technical project issues to PV manager.
• Participates in scoping and supports proposal preparation.
• Improves processes within the unit, oversees project team members, and ensures high-quality work.
• Oversee the work performed by the project team members (Global Drug Safety associates and assistants) and ensure a high standard and quality of delivered work

KEY RESPONSIBILITIES:

• Works on assigned projects and tasks.
• Organizes meetings with project members.
• Ensures project/task delivery aligns with client needs and contractual agreements.
• Achieves personal and departmental KPIs.
• Acts as process owner for assigned PV processes and provides training as required.
• Participates in internal and external training sessions.
• Enhances teamwork and considers client and internal feedback for efficiency and quality improvement.
• Manages relationships with stakeholders, ensures compliance with processes and project deliverables, and handles CAPAs.
• Collaborates cross-functionally with stakeholders/customers.
• Participates in business meetings, bid defenses, audits, inspections, marketing, and promotional activities as needed.
• Organizes and files documents, uses company databases, systems, and IT tools according to company procedures, and adheres to company processes and systems

• Bachelor’s degree or graduate in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences) – advanced degree (e.g., masters) preferable or sufficient relevant experience
• Minimum of 3 years of experience working in a medical or safety department with robust knowledge of medical terminology or sufficient experience as assessed by the Head of Function
• Sound knowledge of Drug Safety processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.,)
• Significant experience working with a safety database
• Fluent verbal and written English
• Excellent team player
• Organizational and time-management skills, able to prioritize work and adhere to deadlines
• Excellent communication skills
• Maintains a positive, result oriented work environment

• Friendly work environment
• Multinational team with 30 nationalities
• Flexible working hours, working from home
• Remote work is possible
• Dog Friendly office