Client Dedicated Safety Writer II

20735023 PPD Serbia D.O.O

Location: PL
Work arrangement: Remote
Job type: Full-time
Posted 10 days ago

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Key skills in this ad

Skills and tools

Clinical research
Project management
Risk management
Cleaning
Procurement
Game development

Experience

5+ years

Languages

English

Qualifications

About this role

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

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.
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

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.

Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary [stories](https://jobs.thermofisher.com/global/en/discover-our-stories) and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell?

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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