Senior Safety Specialist

This is a fully remote position, open to applicants in Poland, +2 more countries.

📋 Description

• Act as the primary Product Safety Lead for designated moderate- to high-complexity studies.

• Oversee study-level safety governance, encompassing the planning, execution, and supervision of safety data collection, processing, and reporting.

• Create, author, and sustain study-specific Safety Management Plans.

• Serve as the main Product Safety liaison for sponsors and internal project teams.

• Handle safety-related communication and resolution of issues.

• Facilitate study-level safety meetings, document discussions, and monitor action items.

• Manage the scope, timelines, and budgets related to study-level safety.

• Recognize and escalate risks that may impact deliverables, quality, or compliance.

• Supervise safety start-up and close-out processes while maintaining inspection-ready documentation.

• Mentor Product Safety Specialists and Associates, including reviewing their deliverables and addressing complex issues.

• Assist in proposal development and bid defenses with insights on study-level safety strategy and operations.

• Execute preliminary or routine risk assessments.

• Engage in training and mentoring of junior safety team members.

⛳️ Requirements

• A Bachelor’s degree (e.g., RN, Health Sciences, PharmD) or an equivalent combination of education and relevant product safety or clinical research experience, along with over 5 years of experience in product safety/pharmacovigilance.

• A minimum of 2 years of experience as a Product Safety Lead in Clinical Trials is mandatory, including the development of Safety Management Plans and site training materials as well as supporting inspections.

• Familiarity with Argus is preferred; proficiency in business productivity software (Excel, Word, PowerPoint, etc.) is required.

• Comprehensive understanding of safety data collection, processing, and reporting standards.

• In-depth knowledge of global regulatory guidelines for pharmacovigilance.

• Advanced expertise in safety database applications and MedDRA/WHO Drug coding.

• Fluency in both English and the local language.

• Strong verbal, written communication, and presentation skills.

• Capability to collaborate effectively within a team environment.

• Excellent judgment in complex or ambiguous situations.

• High attention to detail, including the ability to identify issues, inconsistencies, or risks, ensuring that work products are thorough and dependable.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible working arrangements to promote work-life balance.

• Collaborative and inclusive work environment.