Product Safety Specialist II

Overview

Join us in redefining what it means to work for a CRO. Working at Rho, you’ll be joining a team who take healthcare and clinical research personally, with shared experiences that drive a passion to heal, cure and solve some of humanity’s biggest challenges.

At Rho, we’re committed to you just as you’re committed to us. You’ll have the opportunity to experience a thriving company with real stability - financial, workforce, and corporate, which has created a safe environment to innovate and develop over a long and rewarding career.

With a collaborative team of smart, talented, and positive people, you’ll be celebrated and respected for your expertise and given the freedom to think creatively, challenge the norm, and problem-solve.

We are currently seeking a Product Safety Specialist II to join our team! In this role, you will have the opportunity to play as an integral part of the product safety team and will oversee the day-to-day activities for your assigned projects.

Our Product Safety team will tell you, joining Rho has been one of their best career moves in terms of contentment, financial rewards and career growth, which is why we have such stability in the group!

Responsibilities

• Prepare safety related documents, including safety management plans and site training materials
• Collaborate with internal project teams and sponsors to determine the scope and specifics of safety data collection, processing, and reporting
• Ensure maintenance of adverse event files and documentation
• Perform initial assessment of all safety reports for potential expedited reporting to the FDA or other applicable health authorities
• Reconcile between the clinical and safety database
• Author safety case narratives
• Generate queries to investigators, in conjunction with the internal / external Medical Monitor / Reviewer
• Train clinical site personnel on safety reporting procedures

Qualifications

Bachelor’s degree in a scientific or health related field (e.g. RN, Medical Terminology, Pharm.D) along with at least 2-3 years of product safety / pharmacovigilance experience (clinical trials experience preferred);

experience utilizing product safety database (Argus a plus)

• Strong Communicator : Demonstrate written, verbal and presentation skills to help showcase the successes of your work and Rho’s
• Committed to Quality : Every job at Rho requires an attention to detail, a deep understanding of our high-quality scientific standards, and an ability to care about every outcome
• High-Character : Contribute to our collaborative culture with honesty and integrity. At Rho, we value a strong team spirit highlighted by loyalty, accountability, and mutual trust.

We work smart together, we work hard together, and we laugh together. We take responsibility for our actions, forgive honest mistakes and respect one another

Critical Thinker : Rho values thinking. Draw on your native ingenuity, sharpened and enhanced by our intellect, training, and experience.

We evaluate situations and opportunities objectively and incisively; we then craft novel, practical solutions

Agile and Adaptable : Rho values the ability to change quickly. We eagerly anticipate, respond to, and take advantage of changes in our environment.

We embrace risk but manage it by planning, accepting, and learning from both failures and successes. The opportunity to adapt and evolve energizes us.

A few more things to know about us :

Benefits : Rho provides a comprehensive benefits package for all benefit-eligible employees, which includes medical, vision, dental, HSA, FSA, EAP, life & disability insurance and 401(k).

All employees are eligible for paid time off, holidays, parental leave and bereavement leave.

Diversity and Inclusion : As a global, full-service CRO driven by our collective experiences, we view each of our backgrounds as a vital component in our formula for success and we strive towards building a more equitable, inclusive, and diverse environment for our employees every day.

By valuing and tapping into each employee’s unique and different personal experiences, we are able to uplift employee dignity and belonging, foster more strategic creativity, and more quickly arrive at breakthrough solutions that help us heal the world.

Flexibility : We encourage a work-life balance that allows employees to bring their best selves to work while being passionate about their lives outside work.

As required by pay transparency laws in some states, Rho provides the range of starting compensation (annual salary or hourly rate) it reasonably expects to pay for a given role.

Actual compensation is influenced by a wide array of factors including but not limited to role responsibilities and location as well as candidate skill set and level of experience.

The range of starting pay for this role is $80,000 to $105,000 per year.

EOE. Veterans / Disabled

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