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