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About Company

At Thermo Fisher Scientific, we are at the forefront of clinical research services, bringing scientific and clinical expertise to develop drugs addressing the world’s most challenging health concerns. Our Clinical Research team, powering the PPD® clinical research portfolio, is a leading global contract research organization (CRO).

Position Name :

Safety Writer

Organization :

Thermo Fisher Scientific


B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences


2 Years


8 Lacs Per Anum


Work From Home

The Safety Writer is responsible for planning, coordinating, and delivering safety writing services for multiple clinical trial and/or marketed product projects within a regulated pharmacovigilance environment, adhering to strict timelines. This role involves project management, data review, authoring, and quality review of safety writing deliverables, including line listing reports, Periodic Adverse [Drug] Experience Reports (PA[D]ERs), and potentially more complex reports like Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs).

Essential Functions:

  • Conduct data review, authoring, and quality review tasks on low complexity safety writing deliverables.
  • Support authoring of medium complexity deliverables under supervision.
  • Use multiple company and client systems and interact with project team members and clients.
  • Serve as the primary point of contact for assigned safety writing deliverables.
  • Ensure compliance with company policies, procedures, contractual agreements, and regulations.
  • Stay updated on current regulations, practices, and procedures through review of regulatory/pharmacovigilance publications and information sources.
  • Manage communications and data requests, and participate in kick-off meetings, client meetings, audits, and inspections.

Education and Experience:

  • Bachelor’s degree or equivalent formal academic/vocational qualification.
  • Previous experience (comparable to 2+ years) providing the knowledge, skills, and abilities required for the job.
  • In some cases, a combination of education, training, and/or directly related experience will be considered sufficient.

Knowledge, Skills, and Abilities:

  • Good knowledge of ICH and US aggregate safety reporting formats for clinical trials and/or marketed products.
  • Attention to detail, data interpretation, and medical-scientific writing skills.
  • Critical thinking and problem-solving skills with ability to escalate issues appropriately.
  • Ability to manage and prioritize tasks and meet strict deadlines with modest supervision.
  • Effective oral and written English communication skills, including paraphrasing skills.
  • Proficient in using Microsoft Office products (Outlook, Word, Excel) and ability to work within multiple systems.
  • Understanding of global regulatory requirements for pharmacovigilance 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 achieve shared goals.

Benefits: Thermo Fisher Scientific offers competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. We provide an innovative, forward-thinking work environment with outstanding career and development prospects.

Application Link

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