Associate Medical Safety Director

About the Role

The medical safety team at Lifelancer is committed to delivering high-quality services that meet the evolving needs of the pharmaceutical industry. As a key member of this team, you will be expected to stay up-to-date with the latest regulatory requirements, industry trends, and medical breakthroughs, and to apply this knowledge to drive continuous improvement and innovation. Your ability to communicate complex medical concepts to diverse stakeholders will be essential in this role, as will your capacity to build strong relationships with clients, colleagues, and partners.

Lifelancer is a dynamic and forward-thinking organization that values collaboration, creativity, and innovation. As a remote-first company, we offer flexible working arrangements that allow our team members to work from anywhere, at any time. We believe in fostering a culture of trust, respect, and inclusivity, and we are committed to supporting the career development and well-being of our team members.

What You Will Do

• Provide medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs)
• Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases as appropriate based on regulatory requirements
• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported
• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile
• Provide coding review of AEs, Past medical history, Concomitant medications or other medical data listings to verify and medically vet clinical data
• Represent safety and clinical data review findings during client meetings
• Provide medical review and edits to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
• Provide medical review and edits of Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
• Provide medical oversight for label development, review, and change
• Provide medical support and attendance at Data Safety Monitoring Board Meetings
• Attend and contribute medical safety evaluation on Safety Monitoring Committees
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
• Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract

What We Are Looking For

• A medical degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education
• Three (3) years of clinical practice experience (e.g., graduate medical training) with two (2) additional years in the pharmaceutical or associated industry in any role
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research, including knowledge of regulations and guidelines pertaining to safety and good clinical practice
• Knowledge of clinical trials and pharmaceutical research process
• Ability to establish and meet priorities, deadlines, and objectives
• Skills in providing consultation and advice on multiple assignments required, as well as initiative and flexibility
• Ability to establish and maintain effective working relationships with clients, colleagues, and partners
• Strong communication and interpersonal skills, with the ability to communicate complex medical concepts to diverse stakeholders

Nice to Have

• Experience working in a remote or virtual team environment
• Familiarity with pharmacovigilance software and systems
• Certification in a related field, such as clinical research or medical safety
• Experience working in a fast-paced, dynamic environment with multiple priorities and deadlines

Benefits and Perks

• Competitive salary and benefits package
• Flexible working arrangements, including remote work options
• Opportunities for professional development and career growth
• Access to cutting-edge technology and tools
• Collaborative and dynamic work environment
• Recognition and reward for outstanding performance
• Comprehensive health and wellness program
• Generous paid time off and holiday policy

• Develop a strong understanding of pharmacovigilance regulations and guidelines to stand out in this role. Stay up-to-date with industry trends and breakthroughs to drive continuous improvement and innovation. Showcase your leadership skills and experience in managing medical safety teams. Highlight your ability to communicate complex medical concepts to diverse stakeholders. Be prepared to provide specific examples of your experience in medical safety and pharmacovigilance during the interview process. Leverage your knowledge of clinical trials and pharmaceutical research to drive business outcomes. Consider obtaining certification in a related field to demonstrate your expertise and commitment to the profession.