Global Safety Lead

at  Fortrea

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
As a Global Safety Lead in our sponsor-dedicated Flexible Solutions business unit, you should have vast experience in pharmacovigilance, ICSR, Aggregate, Signal, Risk management.
Qualification and experience:
For MD, two (2) years minimum working experience as a physician in patient care or minimum three (3) years relevant industry experience.

Job Responsibilities:

• Oversees the safety signal detection and medical signal evaluation process.
• Safety Signal confirmation and accountability.
• Oversees safety management teams ensuring a thorough and consistent approach to the review of safety data emerging from clinical trials and from the post-marketing environment.
• Chairs the Safety Management Team.
• Represents GSPV in relevant cross functional teams.
• Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety.
• Oversees analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion.
• Oversee Product Labelling updates from a safety perspective.
• Reviewing local reports drafted by local PV Representatives.
• Serve as SME to stakeholders for assigned products.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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• Oversees the safety signal detection and medical signal evaluation process.
• Safety Signal confirmation and accountability.
• Oversees safety management teams ensuring a thorough and consistent approach to the review of safety data emerging from clinical trials and from the post-marketing environment.
• Chairs the Safety Management Team.
• Represents GSPV in relevant cross functional teams.
• Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety.
• Oversees analysis of aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports) and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion.
• Oversee Product Labelling updates from a safety perspective.
• Reviewing local reports drafted by local PV Representatives.
• Serve as SME to stakeholders for assigned products