Work Schedule
Other

Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

• Conducts data review, authoring, quality review, and senior review tasks on, and project manages a wide range of clinical trial and marketed product safety writing deliverables. These include low complexity (e.g. line listing reports; Periodic Adverse [Drug] Experience Reports (PA[D]ERs)), moderate complexity (e.g. Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), development Risk Management Plans (dRMPs)) and high complexity (Risk Management Plans (RMPs), marketing authorization dossier content, customized safety writing deliverables and regulatory authority assessment report responses) deliverables.
• May additionally provide support for scientific safety services on an ad-hoc basis.
• Uses multiple PPD and client systems. Interacts with PPD/Evidera project team members and clients.
• Functions in a lead role, serving as the primary point of contact for assigned safety writing deliverables. Exercises independent judgment to troubleshoot and resolve project issues and to identify areas for improvement. Mentors less experienced staff.
• Ensures that assigned safety writing and project management tasks are conducted in accordance with company policies and procedures, contractual agreements and applicable regulations.
• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices and procedures.
• Participates in departmental initiatives; Serves as a subject matter expert in designated area.
• Performs routine project implementation and coordination activities for assigned safety writing projects (including functional service provider clients), including leading kick-off meetings, managing communications and data requests, participating in client meetings, audits and inspections, and reviewing of metrics and budgets.

• Bachelor's or higher scientific degree.
• Excellent English - both written and verbal.
• Advanced knowledge of Microsoft Office package.
• Task based project management experience and experience with interacting directly with clients.
• Good understanding and knowledge of aggregate safety report writing guidelines, and clinical trial and post-marketing pharmacovigilance.
• Experience of authoring device aggregate safety reports or clinical evaluation reports is preferable, although not essential.
• Must have a minimum of 4 years' experience in authoring two or more of the following report/document types for medicinal products:
  • DSURs (Development Safety Update Reports)
  • PBRERs / PSURs (Periodic Benefit Risk Evaluation Reports / Periodic Safety Update Reports)
  • PA(D)ERs (Periodic Adverse [Drug] Experience Reports)
  • RMPs (Risk Management Plans)