Job Title: Manager, PV – Safety Writing
Location: Remote, India
Company: Thermo Fisher Scientific
Employment Type: Full-time
Salary: ₹22 LPA – ₹38 LPA (Estimated)
Job Description
Thermo Fisher Scientific is looking for an experienced Manager, PV – Safety Writing to lead pharmacovigilance safety writing operations within its Clinical Research Services team. In this role, you will oversee the preparation and delivery of global safety reports and risk management documentation while ensuring compliance with regulatory requirements and internal quality standards.
You will manage a team of safety writers, coordinate cross-functional safety writing activities, and ensure timely delivery of safety documentation supporting both clinical development programs and marketed products.
Key Responsibilities
Manage preparation and delivery of global aggregate safety reports and pharmacovigilance documentation.
Oversee development of Risk Management Plans (RMPs), regulatory assessment responses, and custom safety reports.
Ensure safety writing deliverables comply with company policies, contractual obligations, and global regulatory requirements.
Collaborate with cross-functional teams to coordinate safety writing activities.
Prepare and support proposals, bids, and client presentations related to safety writing services.
Participate in client meetings, audits, and regulatory authority inspections.
Contribute to departmental initiatives and process improvement projects.
Stay updated with evolving pharmacovigilance regulations and reporting practices.
Manage and mentor safety writing staff including hiring, performance management, coaching, and professional development.
Approve time records, leave requests, and expense reports while supporting operational and budget discussions.
Required Qualifications
Bachelor’s degree or higher in a scientific discipline.
5+ years of safety writing experience in pharmacovigilance or clinical research.
At least 1 year of leadership or team management experience.
Experience working with global pharmacovigilance reporting and safety documentation.
Skills & Competencies
Strong knowledge of Risk Management Plans (RMPs) and ICH / US aggregate safety reporting formats.
Excellent medical-scientific writing and data interpretation skills.
Strong project management and time management abilities.
Proficiency with Microsoft Office tools and safety databases.
Excellent written and verbal communication skills in English.
Strong critical thinking, decision-making, and problem-solving abilities.
Advanced understanding of global pharmacovigilance regulations and compliance standards.
Work Environment
Office-based or remote work environment.
Regular interaction with global clients and project teams.
Occasional domestic or international travel may be required.
Work may involve high concentration and tight project timelines.
About the Company
Thermo Fisher Scientific is a global leader in scientific research services and clinical development. Through its PPD® clinical research portfolio, the company supports pharmaceutical and biotechnology organizations worldwide in bringing innovative therapies and life-saving medicines to market
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