Director, Medical Safety Scientist

🕒 June 29

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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

• Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program • Ensures that processes and procedures are up to date to meet regulatory requirements and inspection readiness • Drives signal management process using available methodologies, including making recommendations for the assessment and prioritization of safety concerns • Effectively communicates with members of the interdisciplinary team regarding ongoing signal evaluation • Ensures that available safety information is evaluated in order to meet both internal and external requirements, including identifying the need for labeling updates. Produces accurate and fit for purpose evaluation documents with clear conclusions, as required • Leads the coordination of aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections, as appropriate • Authors or provides guidance for the production of risk management plans (RMPs) • Provides strategic input into regulatory requests / responses • Delivers clinical safety input into clinical development program • Leads the medical safety contributions of global regulatory submissions for new products, formulations or indications • Participate in and/or lead internal safety surveillance meetings as well as joint safety meetings with licensing Partners, as needed • Provides medical safety input into creation / review of Safety Data Exchange Agreements and/or other PV agreements • Escalates issues / concerns to senior management in a timely and appropriate manner • Mentors and trains junior members of the Medical Safety team

🎯 Requirements

• At least 8 years of experience in drug safety, including at least 5 years of experience in surveillance / risk management • Ability to independently search clinical safety and literature databases for relevant information • Expert knowledge of pharmacovigilance regulations regarding aggregate safety reports, risk management plans, and signal management • Excellent medical writing skills, as well as proven ability to effectively lead interdisciplinary teams • In-depth knowledge of medical and drug terminology, as well as the clinical development process • Familiarity with MedDRA and safety databases; Proficient with Windows applications, and ability to learn new programs / databases

🏖️ Benefits

• medical, dental and vision insurance • retirement savings plan • flexible paid vacation