Safety Writer Job at Thermo Fisher Scientific

Thermo Fisher Scientific is hiring for the role of Safety Writer!

Responsibilities of the Candidate:

• 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. 
• Review 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.

Requirements:

• 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 the 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 the use of Microsoft Office products (including Outlook, Word, and Excel) 
•  Good understanding of the global regulatory requirements pertaining to pharmacovigilance and the importance of 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