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.

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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