Senior Principal Scientist, Drug Safety

🔥 0 minutes ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $282.2k - $444.2k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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MSD

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1891

🏥 Healthcare

📦 Logistics

🧬 Biotechnology

Healthcare • Logistics • Biotechnology

MSD is a leading biopharmaceutical company known as Merck & Co. , Inc. in the United States, Canada, and Puerto Rico, and as MSD globally. The company focuses on scientific innovation to deliver medicines and vaccines for various health challenges, including oncology, vaccines, infectious diseases, and cardio-metabolic diseases. MSD operates multiple divisions, including Human Health, Animal Health, and Research & Development. With approximately 75,000 employees worldwide and a significant investment in research and development, MSD is committed to improving global health through its scientific advancements. Additionally, the company places a strong emphasis on diversity, inclusion, and corporate responsibility. MSD’s operations extend worldwide, offering opportunities in numerous regions and promoting diversity and innovation in all aspects of its business.

📋 Description

• Lead overall clinical risk management and safety surveillance for assigned investigational and marketed products • Chair Risk Management Safety Teams and lead development and maintenance of risk management and pharmacovigilance plans • Participate in Product Development Teams, internal and joint internal/external research teams, and related sub-teams • Partner with clinical development and clinical research to support robust safety assessment and benefit-risk evaluation • Collaborate with clinical development, epidemiology, regulatory affairs, statistics, and manufacturing teams on safety topics • Evaluate safety data from clinical trials, literature, and post-approval use • Ensure completeness of safety information in company core data sheets • Develop scientific strategy for safety-related documents, including CTD components, Risk Management Plans, and Periodic Safety Update Reports • Ensure safety sections of product circulars are medically and scientifically appropriate • Conduct aggregate clinical trial data analyses and post-approval safety signal reviews • Oversee safety surveillance activities with the CSRM Associate • Recommend pharmacovigilance actions, labeling changes, risk management plans, and risk minimization activities • Review and approve product labeling files in the safety database using MedDRA knowledge • Prepare safety summaries and analyses for regulatory documents, aggregate reports, and regulatory filings • Supervise CSRM medical associates in safety data analysis and regulatory document authoring as needed • Participate in developing, implementing, and evaluating department standards, processes, metrics, and initiatives

🎯 Requirements

• MD, DO, or equivalent required • Minimum of 3 years clinical experience following post-graduate medical training or other relevant clinical experience • Prior experience in drug development, including clinical development and/or regulatory experience • Experience in clinical safety, pharmacovigilance and/or risk management • Demonstrated organizational leadership skills, preferably in the noted employment areas • Excellent communication, writing, and analytic skills • Knowledge of Clinical Development, Clinical Risk Management, Clinical Safety, Clinical Training, Drug Development, Drug Safety Surveillance, Pharmacovigilance, Regulatory Documents, Risk Management, and Safety Assessment Reports • Board Certification preferred • Must be a US or Puerto Rico resident • No visa sponsorship available

🏖️ Benefits

• Annual bonus • Long-term incentive, if applicable • Medical, dental, and vision healthcare • Other insurance benefits for employee and family • Retirement benefits, including 401(k) • Paid holidays • Vacation • Compassionate and sick days • Remote work arrangement • Relocation not provided

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