ortrea, a leading global contract research organization (CRO), is currently hiring for two critical roles in Mumbai: Safety Writer and Safety Writing Assistant II. These full-time positions offer an excellent opportunity for professionals passionate about clinical development and pharmacovigilance to contribute to global drug and device development. With operations in over 100 countries, Fortrea is dedicated to transforming the clinical trial process and delivering life-changing therapies to patients worldwide.
Job Overview: Safety Writer
As a Safety Writer, you will play a pivotal role in preparing and reviewing safety reports for global regulatory submissions. Your responsibilities will include:
- Writing and contributing to safety reports such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs), and Annual Reports (IND).
- Leading kick-off meetings, roundtable discussions, and comment resolution processes.
- Performing quality reviews of safety reports prepared by junior or associate medical writers.
- Collaborating with internal and client stakeholders to ensure timely delivery of high-quality documents.
This role requires a strong understanding of regulatory requirements, excellent writing skills, and the ability to manage multiple deliverables efficiently.
Job Overview: Safety Writing Assistant II
The Safety Writing Assistant II role is designed to support medical writers in preparing and reviewing aggregate safety reports and risk management documents. Key responsibilities include:
- Assisting in data collection, strategy execution, and report content development.
- Preparing data summaries, literature abstracts, and other report components.
- Supporting signal detection activities, including data cleaning and review of line listings.
- Contributing to the preparation of ad hoc reports and regulatory documents such as Common Technical Document (CTD) Summaries.
This role is ideal for candidates with a foundational understanding of pharmacovigilance practices and a desire to grow in the pharmaceutical industry.
Why Join Fortrea?
Fortrea is committed to fostering a diverse and inclusive workplace where employees can thrive. As an Equal Opportunity Employer, Fortrea ensures that all employment decisions are based on business needs and individual qualifications, without discrimination.
Key Benefits of Working at Fortrea:
- Opportunity to work on global projects across 20+ therapeutic areas.
- Collaborative and supportive work environment that encourages personal and professional growth.
- Commitment to innovation and transforming the clinical development process.
Qualifications and Requirements
For Safety Writer:
- Minimum of a first degree in life sciences or equivalent.
- Experience in authoring safety reports for regulatory submissions.
- Strong understanding of pharmacovigilance practices and ICH GCP guidelines.
- Excellent written and verbal communication skills.
For Safety Writing Assistant II:
- Minimum of a first degree in life sciences or equivalent.
- At least 6 months to 1 year of experience in the pharmaceutical industry.
- Proficiency in MS Office and strong organizational skills.
- Knowledge of regulatory requirements and good pharmacovigilance practices.
Preferred Qualifications:
- Advanced degree (e.g., PhD or Masters) in life sciences.
- Scientific or clinical research experience.
Application Link For Safety Writer
