Manager, Pharmacovigilance (PV) – Safety Writing
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research
Work Model: Fully Remote
Job ID: R-01342270
Company: Thermo Fisher Scientific
About the Organization
Thermo Fisher Scientific, through its clinical research portfolio including PPD®, operates as a leading global Contract Research Organization (CRO). The organization supports the development and commercialization of innovative therapies by delivering high-quality clinical and pharmacovigilance services worldwide.
Role Overview
The Manager, PV – Safety Writing is responsible for leading global safety writing operations, ensuring the delivery of high-quality pharmacovigilance documentation in compliance with international regulatory standards. This leadership role oversees aggregate safety reporting, risk management plans, and regulatory response documentation for both investigational and marketed products.
The position requires strong expertise in drug safety reporting, regulatory frameworks, and team management within a global clinical research environment.
Key Responsibilities
Global Safety Writing & Regulatory Reporting
Manage preparation and delivery of global aggregate safety reports, including PSURs/PBRERs and DSURs.
Oversee development of Risk Management Plans (RMPs) and responses to regulatory authority assessment reports.
Ensure compliance with ICH guidelines and US/global aggregate reporting requirements.
Contribute to pharmacovigilance procedural documents and regulatory updates.
Operational & Client Management
Allocate appropriate team resources to meet contractual, regulatory, and company standards.
Prepare proposals, bids, and participate in business development initiatives.
Support client meetings, audits, inspections, and internal governance reviews.
Communicate operational, budgetary, and quality updates related to safety writing services.
Leadership & Team Development
Manage and mentor experienced safety writing professionals.
Lead recruitment, onboarding, performance management, and professional development activities.
Approve salary administration, corrective actions, leave requests, and time records.
Drive continuous improvement initiatives within the pharmacovigilance department.
Compliance & Quality Oversight
Maintain awareness of evolving pharmacovigilance regulations and industry standards.
Ensure adherence to global regulatory requirements and internal SOPs.
Support departmental task forces focused on process optimization and quality enhancement.
Education & Experience Required
Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, or related scientific discipline.
Minimum 5+ years of pharmacovigilance safety writing experience.
At least 1+ year of leadership or people management experience.
Strong working knowledge of ICH guidelines, global aggregate reporting formats, and RMP requirements.
Equivalent combinations of education, training, and directly related experience may be considered.
Key Skills & Competencies
Advanced knowledge of global pharmacovigilance regulatory frameworks.
Expertise in risk management plans and aggregate safety reporting.
Strong medical-scientific writing and data interpretation skills.
Excellent project management and time management capabilities.
Proficiency in Microsoft Office applications and safety databases.
Exceptional written and verbal communication skills in English.
Analytical mindset with strong problem-solving and decision-making skills.
Working Conditions
Fully remote role within India.
Standard 40-hour work schedule with flexibility for global collaboration.
Occasional domestic or international travel as required.
Interaction with global stakeholders in a fast-paced clinical research environment.
Why Apply?
This is a strategic leadership opportunity within a globally recognized CRO environment, offering exposure to complex global pharmacovigilance operations, regulatory compliance management, and high-impact safety documentation for innovative therapies.
Keywords: Pharmacovigilance Manager Jobs India, Safety Writing Manager Remote, PV Aggregate Reporting Careers, Risk Management Plan Specialist Jobs, CRO Pharmacovigilance Leadership Roles, Clinical Research Safety Writing Careers India.
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