Associate Medical Director, Medical Safety

🕒 June 29

🏄 California, Pennsylvania – Remote

🏄 California – Remote 🔔 Pennsylvania – Remote

💵 $212k - $318k / year

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• implementing the global safety strategy and monitoring the overall safety profile for products • generating all major pre- and post-marketing safety deliverables including signal and risk management activities • providing Medical Safety/PV inputs to assigned products and liaising with multiple departments • participating in the preparation and review of safety-related clinical and regulatory documents • conducting signal detection activities and ensuring communication of safety assessments to stakeholders • contributing to preparation of Risk Management Plans (RMPs) for assigned products

🎯 Requirements

• MD required (or equivalent) • medical licensure in at least one state preferred • minimum 3 years of Drug Safety/Pharmacovigilance (PV) experience or 3 or more years clinical development experience • understanding of global PV regulatory environment with working knowledge of international regulations, GVP • working knowledge of safety databases (ARISg, ARGUS, or other safety database applications) • MedDRA trained and working knowledge of MedDRA and WHO Drug coding dictionaries • high level of initiative and independence • excellent written and oral communication skills • computer literacy with proficiency in external Regulatory Databases, Microsoft Excel, PowerPoint and Word

🏖️ Benefits

• medical, dental and vision insurance • 401k retirement savings plan • flexible paid vacation • discretionary annual cash bonus or incentive compensation • discretionary equity grants