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- Tasks: Ensure compliance with regulations and process adverse event reports in a dynamic clinical research environment.
- Company: Join Beacon Hill Life Sciences, a leading staffing organisation connecting talent with top pharmaceutical and biotech companies.
- Benefits: Enjoy hybrid work options and the chance to work with innovative teams across the U.S.
- Why this job: Make a real impact in drug safety while developing your skills in a supportive and collaborative culture.
- Qualifications: 2+ years in pharma or biotech, with knowledge of GCP, ICH guidelines, and excellent communication skills.
- Other info: Immediate hiring for a contract-to-perm position in Bethesda.
The predicted salary is between 36000 - 60000 £ per year.
Job Description
SAFETY & PHARMACOVIGILENCE SPECIALIST
Contract to perm
Hybrid in Bethesda
RESPONSIBILITIES
- Ensures compliance with Standard Operating Procedures, Food and Drug Administration and World Health Organization regulations and global regulations for the reporting of adverse events to regulatory agencies
- Develops and ensures the uniform and timely processing of adverse event reports
- Provides medical evaluation of adverse event reports
- Performs various tasks in support of clinical research including the reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development
- Maintains/updates agent-specific clinical and preclinical toxicity study summary tables for investigational agents
- Performs literature searches
- Performs various tasks in support of clinical research including adverse event analysis and processing, serious adverse event reconciliation.
- Preparation of IND safety reports for submission to the FDA; safety document or data analysis.
- Clinical trial site support; reporting, collecting, and sharing of results and issues around adverse event reports both for currently marketed drugs as well as those in the experimental stages of development.
- Assists in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labeling/package inserts, and other reports as necessary.
- May review experimental protocols and informed consent documents; and prepare, review, and edit presentations regarding safety issues.
REQUIREMENTS
- Knowledge of GCP and ICH guidelines preferred; drug development/clinical trial experience essential.
- Knowledge of safety databases and/or MedDRA coding preferred.
- Experience leading clinical and cross functional teams is a plus.
- Must have excellent oral, written, presentation and computer skills.
- 2+ years of academic, pharmaceutical or biotech industry or academic experience.
Company Description
Beacon Hill Life Sciences places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Life Sciences National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Life Sciences matches world class talent with exceptional opportunities.
Company Description
SAFETY & PHARMACOVIGILENCE SPECIALIST (Hiring Immediately) employer: Rac
Contact Detail:
Rac Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land SAFETY & PHARMACOVIGILENCE SPECIALIST (Hiring Immediately)
✨Tip Number 1
Familiarise yourself with GCP and ICH guidelines, as well as the specific regulations related to pharmacovigilance. This knowledge will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotech industries. Attend relevant conferences or webinars where you can meet people who work in safety and pharmacovigilance roles, as they might provide insights or even referrals.
✨Tip Number 3
Stay updated on the latest trends and developments in drug safety and adverse event reporting. Being knowledgeable about current events in the industry can give you an edge during discussions with potential employers.
✨Tip Number 4
Prepare for behavioural interview questions by reflecting on your past experiences in clinical research or pharmacovigilance. Think of specific examples that showcase your problem-solving skills and ability to work in cross-functional teams.
We think you need these skills to ace SAFETY & PHARMACOVIGILENCE SPECIALIST (Hiring Immediately)
Some tips for your application 🫡
Understand the Role: Read the job description thoroughly to understand the responsibilities and requirements of the Safety & Pharmacovigilance Specialist position. Tailor your application to highlight relevant experience and skills that match these criteria.
Highlight Relevant Experience: In your CV and cover letter, emphasise any previous experience in pharmacovigilance, clinical trials, or drug development. Mention specific projects or roles where you ensured compliance with regulations or processed adverse event reports.
Showcase Your Skills: Make sure to include your proficiency in GCP and ICH guidelines, as well as any experience with safety databases or MedDRA coding. Highlight your excellent oral and written communication skills, as these are crucial for the role.
Craft a Strong Cover Letter: Write a compelling cover letter that not only summarises your qualifications but also expresses your enthusiasm for the role and the company. Mention why you are particularly interested in working with Beacon Hill Life Sciences and how you can contribute to their mission.
How to prepare for a job interview at Rac
✨Know Your Regulations
Familiarise yourself with the Standard Operating Procedures, FDA, and WHO regulations relevant to pharmacovigilance. Being able to discuss these confidently will show your understanding of the industry's compliance requirements.
✨Demonstrate Your Experience
Prepare specific examples from your past roles that highlight your experience in drug development and clinical trials. Be ready to discuss how you've handled adverse event reports and your role in ensuring safety compliance.
✨Showcase Your Communication Skills
Since excellent oral and written communication skills are essential for this role, practice articulating your thoughts clearly. You might be asked to explain complex safety data or present findings, so clarity is key.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's approach to pharmacovigilance and their expectations for the role. This not only shows your interest but also helps you gauge if the company aligns with your career goals.
