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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.

This is a great opportunity for experienced Safety Writers currently working within the life science sector for pharmaceutical companies, biotech companies or Clinical Research Organizations (CROs), to work for a global leading CRO.

As the trusted partner of some of the most innovative big pharma and biotech companies, our Safety Writers have the opportunity to work on challenging projects across a wide range of therapeutic areas. Our vision is to be the global leader in our industry based on consistent quality and execution, exceptional customer-aligned service and constant innovation.

You should have significant scientific or medical writing experience, thrive in project teams and be focused on delivering exemplary levels of customer service. Capable of concise and clear written and verbal communication you will be able to understand, interpret, analyze and present complex data and have a high attention to detail. As you may be working on multiple reports at the same time, you should have strong organizational skills, including the ability to prioritize work to ensure that strict timelines are adhered to. You must be comfortable with having direct interaction with clients, as you will be responsible for running meetings and managing review and comment resolution stages of document preparation.

In return we will offer you a positive and supportive working environment within one of the most engaged teams in the industry who are recognized as the cornerstone of our success. We will provide you with the opportunity to acquire valuable personal and professional skills.

Summarized Purpose:

Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Activities include but are not

limited to delivery of safety writing deliverables ranging from low to medium complexity through achievement of the following tasks: project management, data review, authoring, and quality review. May also support authoring of higher complexity deliverables. Effectively collaborates with various parties, including but not limited to: PVG project team members, wider PPD/Evidera project team members, client contacts and third-party vendors.

Essential Functions:

• 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 authorization 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.

Qualifications

• Bachelor’s or higher scientific degree.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years).

• 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 two 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)

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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.