Safety and Pharmacovigilance Expert
5 days ago
We are seeking a highly skilled Safety and Pharmacovigilance Specialist to join our team at Beacon Hill Life Sciences - Boston. As a key member of our clinical research team, you will be responsible for ensuring the safety of participants in clinical trials and providing critical support to our pharmaceutical and biotech clients.
Key Responsibilities- Adverse Event Analysis and Processing: Perform thorough analysis and processing of adverse events to ensure accurate and timely reporting to regulatory authorities.
- IND Safety Reports: Prepare and submit IND safety reports to the FDA, ensuring compliance with regulatory requirements.
- Safety Document and Data Analysis: Conduct in-depth analysis of safety data and documents to identify trends and patterns.
- Clinical Trial Site Support: Provide critical support to clinical trial sites, including training and guidance on safety protocols and procedures.
- Medical Degree: Must hold a medical degree from an accredited institution (M.D. or D.O.).
- Industry Experience: Must have a minimum of 3 years of experience in the pharmaceutical or biotech industry, with a focus on clinical research and safety.
- Knowledge of GCP and ICH Guidelines: Must have in-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.
- Leadership Skills: Must have excellent leadership and communication skills, with the ability to lead cross-functional teams and communicate complex safety information to stakeholders.
Beacon Hill Life Sciences - Boston is an Equal Opportunity Employer that values the strength diversity brings to the workplace. We are committed to creating a workplace that is inclusive and respectful of all individuals, regardless of their background, culture, or identity.
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Senior Chemical Safety Specialist
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