Safety Writer IV

Safety Writer IV - Thermo Fisher Scientific

Join Thermo Fisher Scientific as a Safety Writer IV and contribute to critical pharmacovigilance activities, ensuring patient safety at the forefront of innovation.

About the Role

As a Safety Writer IV, you will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and/or marketed product projects. You will perform day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Your activities will include project management, data review, authoring, quality review, and senior review for deliverables ranging from low to high complexity. You may also provide support for scientific safety services and lead departmental initiatives.

Key Responsibilities:

• Conduct data review, authoring, quality review, and senior review for a wide range of clinical trial and marketed product safety writing deliverables.
• Project manage deliverables including low complexity (e.g., line listing reports, PA(D)ERs), moderate complexity (e.g., DSURs, PSURs/PBRERs, dRMPs), and high complexity (e.g., RMPs, marketing authorization dossier content, regulatory authority assessment report responses).
• Serve as a consultant on higher complexity deliverables and provide support for scientific safety services on an ad-hoc basis.
• Utilize multiple PPD and client systems, interacting effectively with project team members and clients.
• Function in a lead role, serving as the primary point of contact for assigned safety writing deliverables and troubleshooting project issues.
• Support management with delegated oversight of team training and mentoring.
• Ensure all tasks are conducted in accordance with company policies, procedures, contractual agreements, and applicable regulations.
• Stay updated on current regulations, practices, and procedures by reviewing regulatory/pharmacovigilance publications.
• Participate in and lead departmental initiatives, serving as a subject matter expert.
• Perform routine project implementation and coordination activities, including leading kick-off meetings, managing communications, and participating in client meetings, audits, and inspections.

Education and Experience:

• Bachelor's or higher scientific degree.
• Minimum of eight years' experience in authoring and quality control review of DSURs, PBRERs/PSURs, PA(D)ERs, and RMPs for innovative medicinal products.

Knowledge, Skills, and Abilities:

• Highly skilled in ICH and US aggregate safety reporting formats.
• Excellent attention to detail, data interpretation, and medical-scientific writing skills.
• Advanced critical thinking and problem-solving abilities.
• Great project management skills with the ability to manage multiple projects simultaneously.
• Ability to motivate, mentor, and provide guidance to less experienced staff.
• Advanced project administration skills, including budget activities and forecasting.
• Excellent oral and written English communication skills.
• Exceptional computer skills with proficiency in Microsoft Office Suite.
• Advanced understanding of global regulatory requirements in pharmacovigilance.
• Ability to maintain a positive and professional demeanor in challenging circumstances.
• Ability to work effectively within a team.

Working Conditions:

• Office environment.
• Daily exposure to high pressure and intense concentration.
• Daily interactions with clients/associates.
• Long, varied hours on occasion.
• Travel required on occasion (domestic and/or international).

Why Join Us?

Join Thermo Fisher Scientific and become part of a global team that values passion, innovation, and scientific excellence. You'll work in an environment where collaboration and development are integral, and your contributions make a real difference in delivering tomorrow's breakthroughs.

Key skills/competency

• Safety Writing
• Pharmacovigilance
• Clinical Trials
• Regulatory Affairs
• DSUR
• PSUR
• PBRER
• Risk Management Plans (RMPs)
• Data Review
• Project Management