Join Our Team as a Safety & Pharmacovigilance Specialist!
Are you passionate about ensuring the safety of pharmaceutical products? Do you thrive in a dynamic environment where your expertise can make a real difference? If so, we have an exciting opportunity for you!
Position Overview
Role: Safety & Pharmacovigilance Specialist
Type: Contract to Permanent
Location: Hybrid in Bethesda
Your Responsibilities
As a Safety & Pharmacovigilance Specialist, you will play a crucial role in maintaining compliance and ensuring the safety of our products. Your key responsibilities will include:
* Ensuring adherence to Standard Operating Procedures and regulations from the FDA and WHO.
* Developing and processing adverse event reports in a timely manner.
* Providing medical evaluations of adverse event reports.
* Supporting clinical research by reporting, collecting, and sharing results related to adverse events.
* Maintaining and updating clinical and preclinical toxicity study summaries for investigational agents.
* Conducting literature searches to support safety evaluations.
* Preparing IND safety reports for FDA submission and conducting safety data analysis.
* Assisting with clinical trial site support and communication regarding adverse events.
* Preparing safety updates for new drug applications and other necessary reports.
* Reviewing experimental protocols and informed consent documents, and preparing presentations on safety issues.
What We’re Looking For
To excel in this role, you should meet the following qualifications:
* Knowledge of GCP and ICH guidelines is preferred; experience in drug development and clinical trials is essential.
* Familiarity with safety databases and/or MedDRA coding is a plus.
* Experience leading clinical and cross-functional teams is advantageous.
* Exceptional oral, written, presentation, and computer skills.
* A minimum of 2 years of experience in the academic, pharmaceutical, or biotech industry.
Why Join Us?
At Beacon Hill Life Sciences, we believe in matching world-class talent with exceptional opportunities. Here’s what you can expect:
* Growth Opportunities: We support your professional development and career advancement.
* Flexibility: Enjoy a hybrid work environment that promotes work-life balance.
* Impact: Contribute to meaningful projects that enhance patient safety and well-being.
About Beacon Hill Life Sciences
Beacon Hill Life Sciences, a part of BHSG, is a national staffing organization dedicated to providing top-notch staffing solutions to the pharmaceutical, medical device, biotech, and contract research sectors. We pride ourselves on our ability to place contractors in all 50 states, seamlessly coordinating local and national recruiting efforts.
Whether you’re looking to join a start-up or a Fortune 500 company, we are committed to connecting you with exceptional opportunities that align with your career goals.
Ready to take the next step in your career? Join us and make a difference!