Safety Writer III
Organization: Thermo Fisher Scientific (Clinical Research Services – PPD Portfolio)
Location: Remote, India
Job Type: Full-Time, Fully Remote
Job ID: R-01343013
Category: Clinical Research / Pharmacovigilance / Drug Safety
Work Schedule: Monday to Friday
About the Organization
Thermo Fisher Scientific is a global leader in scientific research and clinical development services, supporting pharmaceutical and biotechnology companies in bringing innovative therapies to market. Through its PPD clinical research portfolio, the organization delivers end-to-end clinical research solutions, pharmacovigilance services, and regulatory support across global clinical trials.
The Clinical Research Services team collaborates with leading pharmaceutical organizations and biotechnology companies worldwide, ensuring high-quality scientific and safety standards throughout drug development and post-marketing surveillance processes.
Job Overview
The Safety Writer III is responsible for planning, coordinating, and delivering safety writing services for clinical trials and marketed products within a regulated pharmacovigilance environment. The role involves preparing regulatory safety documents, reviewing clinical and safety data, and managing safety reporting deliverables across multiple projects.
The selected candidate will lead safety writing initiatives, collaborate with cross-functional teams, mentor junior staff, and ensure compliance with global regulatory requirements and project timelines.
Key Responsibilities
Perform data review, authoring, quality review, and senior review of safety writing deliverables for clinical trials and marketed products.
Prepare safety reports of varying complexity, including:
Periodic Adverse Drug Experience Reports (PA(D)ERs) and line listing reports.
Development Safety Update Reports (DSURs).
Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).
Development Risk Management Plans (dRMPs) and Risk Management Plans (RMPs).
Marketing authorization dossier content and regulatory authority responses.
Manage safety writing projects, including planning, coordination, and stakeholder communication.
Serve as the primary point of contact for assigned safety writing deliverables.
Ensure compliance with pharmacovigilance regulations, company policies, and contractual requirements.
Collaborate with project teams, clients, and external vendors to support safety documentation activities.
Provide mentorship and technical guidance to junior team members.
Review regulatory publications and pharmacovigilance updates to maintain current knowledge of industry requirements.
Participate in audits, inspections, and departmental initiatives.
Support scientific safety services and cross-functional project activities as required.
Educational Qualifications
Bachelor’s degree or higher in a scientific discipline such as Life Sciences, Pharmacy, Medicine, or related field.
Experience Required
Minimum 6 years of experience in safety writing and quality review for innovative medicinal products.
Proven experience authoring and reviewing key pharmacovigilance documents, including DSURs, PSURs/PBRERs, PA(D)ERs, and Risk Management Plans.
Experience working in clinical research, pharmacovigilance, or contract research organizations is preferred.
Required Skills and Competencies
Strong expertise in global pharmacovigilance regulations, including ICH and US safety reporting formats.
Advanced medical and scientific writing skills with strong attention to detail.
Excellent data interpretation and analytical capabilities.
Strong project management skills with the ability to manage multiple projects simultaneously.
Ability to mentor and guide junior team members.
Strong problem-solving and critical thinking abilities.
Proficiency in Microsoft Office applications and multiple data management systems.
Excellent written and verbal communication skills in English.
Ability to work collaboratively in a team-oriented environment.
Work Environment and Career Growth
This role provides an opportunity to work at the forefront of clinical research and drug safety, supporting global clinical trials and patient safety initiatives. Employees benefit from a collaborative work culture, professional development opportunities, and exposure to innovative research and regulatory practices.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Tallinn |Hà Nội :
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Santiago |Bosnia and Herzegovina :
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Sofia |Sweden :
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