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