Job Description :

Work Schedule

Standard Office Hours (40/wk)

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 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/Evidera project team members, client contacts, and third-party vendors.

What You'll Do:
. 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.
. May additionally support authoring of high complexity (Risk Management Plans (RMPs), marketing authorisation dossier content, customized safety writing deliverables and regulatory authority assessment report responses) deliverables under supervision from more senior staff.
. 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. Provides assistance in the development of program and departmental procedural documents. 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
. 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 higher scientific degree
. Must have a minimum of five years experience in authoring and quality control review of two or more of the following report/document types for innovative medicinal products:

DSURs
PSURs/PBRERs
PA(D)ERs
RMPs

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 Microsoft Office 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

Working Conditions and Environment:
. Work is performed in an office environment with exposure to electrical office equipment
. 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

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.

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