Safety Writer II
Thermo Fisher Scientific
New Delhi, Delhi, India
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
