Safety Writer III

This is a fully remote position, open to applicants in Greece, +3 more countries.

📋 Description

• Strategize, coordinate, and execute safety writing services for clinical trial and marketed product initiatives.

• Perform data assessment, authoring, quality checks, and senior-level review of safety writing outputs.

• Oversee the project management of safety writing deliverables, ranging from low to high complexity.

• Offer on-demand support for scientific safety services.

• Utilize various PPD and client systems.

• Collaborate with teams from PVG, PPD/Evidera, clients, and third-party vendors.

• Act as the main point of contact for assigned safety writing outputs.

• Identify and resolve project challenges while pinpointing areas for improvement.

• Provide mentorship to junior staff members.

• Ensure compliance with company policies, contracts, regulations, and procedures.

• Review publications related to regulatory and pharmacovigilance matters.

• Engage in departmental initiatives and act as a subject matter expert.

• Lead project kick-off meetings, manage communications, handle data requests, and participate in client meetings, audits, and inspections.

• Analyze project metrics and budgets.

⛳️ Requirements

• Bachelor's degree or an equivalent formal academic/vocational qualification.

• Over 8 years of relevant experience, or comparable knowledge, skills, and abilities.

• A suitable combination of education, training, and/or relevant experience may be accepted as an equivalency.

• Expertise in ICH and US aggregate safety reporting formats for clinical trials and marketed products.

• Familiarity with risk management plans.

• Exceptional attention to detail, data interpretation, and medical-scientific writing capabilities.

• Strong critical thinking and problem-solving abilities.

• Proven project management skills with the capacity to handle multiple projects simultaneously.

• Ability to inspire, mentor, and guide less experienced staff members.

• Proficient in complex project administration, including budget management and forecasting.

• Outstanding oral and written English communication skills, including paraphrasing abilities.

• Advanced computer skills and proficiency in various systems.

• High proficiency in Microsoft Office applications, including Outlook, Word, and Excel.

• Deep understanding of global pharmacovigilance regulatory requirements.

• Capability to adhere to procedural documents, regulations, company policies, and contractual obligations.

• Ability to work effectively within a team setting.

• Occasional domestic and/or international travel may be necessary.

🏝️ Benefits

• Fully remote work setup.

• Standard office hours (40 hours per week).

• Opportunities for professional development and collaboration.

• Mentorship and guidance opportunities available.

• Global team environment.

• Occasional domestic and international travel.