Client Dedicated Safety Writer II

Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Join Us as a Safety Writer II – Make an Impact at the Forefront of Innovation

We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.

As part of our expert team, you’ll have the opportunity to ensure operational excellence that makes a real difference in patient safety. As a Safety Writer II, you will be responsible for the planning, coordination, and delivery of safety writing services for multiple 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, but are not limited to, the delivery of safety writing deliverables ranging from low to medium complexity through tasks such as project management, data review, authoring, and quality review. You may also support the authoring of higher complexity deliverables. You will effectively collaborate with various parties, including but not limited to, PVG project team members, wider PPD project team members, client contacts, and third-party vendors.

Responsibilities

• Conducts data review, authoring, and quality 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)) and 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)) deliverables.
• Uses multiple company and client systems. Interacts with project team members and clients.
• Operates in a lead capacity, serving as the primary point of contact for assigned safety writing deliverables.
• 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.
• Performs routine project implementation and coordination activities for assigned safety writing projects, including leading kick-off meetings, managing communications and data requests, participating in client meetings, audits and inspections, and reviewing metrics and budgets.
• Education and Experience Requirements:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• Knowledge, Skills and Abilities:
• Comprehensive knowledge and experience of ICH and US aggregate safety reporting formats relating to clinical trials and/or marketed products
• Thorough attention to detail; strong data interpretation and medical-scientific writing skills
• Strong critical thinking and problem solving skills with ability to evaluate and escalate appropriately
• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
• Skilled at complex project administration including budget activities and forecasting
• Strong oral and written English language communication skills, including paraphrasing skills
• Solid computer skills with the ability to work within multiple systems; proficient in use of MicrosoftOffice products (including Outlook, Word, and Excel)
• In-depth understanding of the global regulatory requirements pertaining to pharmacovigilance and the importance of and compliance with procedural documents and regulations
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Ability to work effectively within a team to attain a shared goal

Benefits

• When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
• Apply today to help us deliver tomorrow’s breakthroughs.