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 safety writing deliverables ranging from low to medium complexity through achievement of the following tasks: project management, data review, authoring, and quality review. May also support authoring of higher 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 function:

　　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.

　　May additionally support authoring of high complexity (Risk Management Plans

　　(RMPs), marketing authorisation dossier content, customized safety writing

　　deliverables and regulatory authority assessment report responses) deliverables

　　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

　　safety writing deliverables. Provides assistance in the development of program

　　and departmental procedural documents. Mentors less experienced staff.

　　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.

　　Participates in departmental initiatives

　　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.

　　Job Complexity:

　　Works on problems of diverse scope where analysis of data requires evaluation of

　　identifiable factors.

　　Job Knowledge:

　　A seasoned, experienced professional with a full understanding of area of

　　specialization; resolves a wide range of issues in creative ways. This job is the fully

　　qualified, career-oriented, journey-level position.

　　Supervision Received:

　　Normally receives little instruction on day-to-day work, general instructions on new

　　assignments. Demonstrates good judgment in selecting methods and techniques for

　　obtaining solutions.

　　Business Relationships:

　　Represents the department as a prime contact on projects. Interacts with internal

　　and external personnel on significant matters often requiring coordination between

　　functional areas. Networks with senior internal and external personnel in own area

　　of expertise.

　　Qualifications

　　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 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 Microsoft

　　Office 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