Job Description :

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Join Us as a Safety Writer IV - 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 IV, you will be responsible for the planning, coordination, and delivery of safety writing services for clinical trial and/or marketed product projects, including where the company serves as a pharmacovigilance functional service provider to the client in question. 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 high complexity through tasks such as project management, data review, authoring, quality review, and senior review. You may additionally provide support for scientific safety services on an ad-hoc basis. You will effectively collaborate with various parties, including but not limited to, PV project team members, wider PPD/Evidera project team members, client contacts, and third-party vendors. You may directly oversee staff and provide input on individual performance. You may also lead departmental initiatives.

What You'll Do:
. 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.

. Serves as a consultant on higher complexity 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. Serves as primary point of contact in absence of the manager.

. Supports management with delegated oversight of team training/mentoring.
. 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/leads 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.

Education and Experience Requirements:
. Bachelor's or higher scientific degree.
. Must have a minimum of eight years experience in authoring and quality control review of all of the following report/document types for innovative medicinal products:

DSURs
PBRERs/PSURs
PA(D)ERs
RMPs

Knowledge, Skills and Abilities:
. Highly skilled in ICH and US aggregate safety reporting formats relating to both clinical trials and marketed products knowledge of risk management plans
. Excellent attention to detail, data interpretation and medical-scientific writing skills
. Advanced critical thinking and problem solving skills with ability to evaluate and escalate appropriately
. 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 language communication skills, including paraphrasing skills
. Exceptional computer skills with the ability to work within multiple systems advanced skills in Microsoft Office products (including Outlook, Word, and Excel)
. Advanced 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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