Safety Writer II – Clinical Research (Fully Remote)
Location: Remote – India
Function: Clinical Research / Pharmacovigilance
Job Type: Full-Time
Company Overview
Thermo Fisher Scientific, through its PPD clinical research portfolio, is a leading global Contract Research Organization (CRO) supporting pharmaceutical and biotechnology companies worldwide. With extensive experience across global clinical trials, the organization delivers high-quality pharmacovigilance and safety reporting services aligned with international regulatory standards.
Role Overview
The Safety Writer II is a mid-level pharmacovigilance professional responsible for planning, authoring, reviewing, and coordinating aggregate safety reports for clinical trial and marketed products. Working within a highly regulated environment, this role ensures timely and compliant delivery of safety documentation in accordance with global pharmacovigilance regulations.
This position is ideal for experienced safety writers seeking fully remote Pharmacovigilance Safety Writer jobs in India within a global CRO framework.
Key Responsibilities
Aggregate Safety Writing & Review
Perform data review, authoring, quality control review, and project coordination for a range of safety writing deliverables.
Prepare low-complexity reports such as PA(D)ERs and line listing reports.
Author and review moderate-complexity documents including DSURs, PSURs, and PBRERs.
Support development Risk Management Plans (dRMPs).
Assist in drafting high-complexity documents such as RMPs and regulatory authority responses under senior supervision.
Project Management & Coordination
Serve as primary point of contact for assigned safety writing deliverables.
Lead kick-off meetings and manage data requests and stakeholder communications.
Participate in client meetings, audits, and inspections as required.
Support departmental procedural documentation and mentor junior team members.
Assist in tracking project metrics, timelines, and budgets.
Regulatory Compliance & Governance
Ensure safety writing deliverables comply with ICH guidelines, US and global pharmacovigilance regulations, and company SOPs.
Stay updated with evolving regulatory standards and pharmacovigilance best practices.
Maintain strict adherence to contractual and regulatory requirements.
Cross-Functional Collaboration
Work closely with PV project teams, Evidera teams, clients, and third-party vendors.
Utilize multiple company and client systems for document management and reporting workflows.
Educational Qualifications
Bachelor’s Degree or higher in Life Sciences, Pharmacy, Medicine, or related scientific discipline.
Experience Required
Minimum 5+ years of experience in pharmacovigilance safety writing for innovative medicinal products.
Proven experience authoring and performing quality control review for at least two or more of the following:
DSURs
PSURs / PBRERs
PA(D)ERs
Risk Management Plans (RMPs)
Strong understanding of global safety reporting requirements including ICH and US regulations.
Knowledge, Skills & Competencies
Comprehensive knowledge of aggregate safety reporting formats for clinical trials and marketed products.
Strong medical-scientific writing and data interpretation skills.
Excellent attention to detail and analytical ability.
Effective project management skills with ability to manage multiple concurrent assignments.
Advanced proficiency in Microsoft Office (Word, Excel, Outlook).
Strong written and verbal English communication skills.
Ability to work independently and collaboratively within global teams.
Working Environment
Fully remote role within India.
Standard 40-hour work schedule with occasional extended hours depending on project requirements.
Regular interaction with global clients and cross-functional stakeholders.
Occasional domestic or international travel may be required.
Why Join Thermo Fisher Scientific?
Contribute to global pharmacovigilance and clinical research initiatives.
Gain exposure to multinational pharmaceutical and biotech clients.
Work in a collaborative, innovation-driven, and compliance-focused environment.
SEO & GEO Keywords: Safety Writer II Remote India, Pharmacovigilance Safety Writer Jobs India, DSUR PSUR PBRER Jobs Remote, Aggregate Safety Reporting Careers India, Clinical Research Safety Writing Jobs India, Thermo Fisher Scientific Safety Writer Jobs Remote.
This role is designed for experienced pharmacovigilance professionals seeking remote Safety Writer II positions in India with expertise in aggregate safety reporting, regulatory compliance, and clinical research documentation.
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Harrogate |South Yorkshire :
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Tallinn |Hà Nội :
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