Fortrea Hiring Saferty Writer in pharmacovigilance - Apply Online

Fortrea Hiring Saferty Writer in pharmacovigilance – Apply Online

Fortrea is a leading global contract research organization (CRO), renowned for its scientific rigor and decades of clinical development experience. Serving pharmaceutical, biotechnology, and medical device companies, Fortrea offers a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a workforce of over 19,000 employees spanning more than 90 countries, Fortrea is committed to transforming drug and device development, bringing life-changing therapies to patients worldwide.

Position Name : Saferty Writer

Organization : Fortrea

Qualification: PharmD, PhD, MD, or equivalent preferred

Experience: 1 to 2 Years

Salary: Not disclosed

Location: Mumbai

Job Role: Safety Writer
As a Safety Writer at Fortrea, you will be pivotal in the preparation of various safety and regulatory reports. Your responsibilities will include data collection for report planning, strategy development, and leading discussions to resolve report comments. Additionally, you will write safety reports for global regulatory submissions, including:

Annual Reports (IND and others)
Periodic Safety Update Reports (PSUR)
Periodic Adverse Drug Experience Reports (PADER)
Development Safety Update Reports (DSUR)
Risk Management Plans (RMP)

Collaboration with clients and stakeholders will be key to obtaining the necessary inputs for these reports. You will also conduct quality reviews of reports prepared by junior medical writers, write subject narratives for adverse drug reactions and serious adverse events, and contribute to other regulatory documents such as Clinical Summaries and Common Technical Document Summaries.

Qualifications for the Role
To qualify for the position of Safety Writer, candidates should have the following:

Advanced degree in a relevant scientific field (PharmD, PhD, MD, or equivalent preferred)
Proven experience in medical writing and safety report writing
Knowledge of regulatory requirements and pharmacovigilance guidelines
Strong written and verbal communication skills
Ability to lead discussions, collaborate with stakeholders, and meet deadlines efficiently

Essential Skills for Success
In addition to the qualifications, the ideal Safety Writer should possess the following skills:

Attention to detail for quality review of safety reports
Ability to conduct and analyze literature searches for report development
Proficiency in writing clear, concise, and accurate safety documents
Strong project management skills for handling multiple deliverables
High level of customer service orientation, fostering a culture of collaboration and innovation