Safety Writer

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