Thermo Fisher Job Opening for Safety Writer - Apply Now

Thermo Fisher Job Opening for Safety Writer – Apply Now

Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).

Job Description

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 low complexity safety writing deliverables through achievement of the following tasks: project management, data review, authoring, and quality review. May also support authoring of medium 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 range of low complexity clinical trial and marketed product safety
writing deliverables (e.g. line listing reports; Periodic Adverse [Drug] Experience Reports] (PA[D]ERs)).
 May additionally support authoring of medium complexity deliverables (e.g.
Development Safety Update Reports (DSURs), Periodic Safety Update Reports
(PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), development Risk Management Plans (dRMPs)) 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 low complexity safety writing deliverables.
 Ensures that assigned safety writing 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 of activities for
assigned safety writing projects, including managing communications and data requests, and participating in kick-off meetings, client meetings, audits and inspections.

Education and Experience:
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 2+ 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:

 Good knowledge of ICH and US aggregate safety reporting formats relating to clinical trials and/or marketed products
 Good attention to detail; good data interpretation and medical-scientific writing skills
 Solid critical thinking and problem solving skills with ability to escalate appropriately
 Ability to manage and prioritize a variety of tasks and meet strict deadlines with modest supervision
 Effective oral and written English language communication skills, including paraphrasing skills
 Good computer skills with the ability to work within multiple systems; proficient in use of Microsoft Office products (including Outlook, Word, and Excel)
 Good 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