[Hiring] Senior Principal Scientist @Merck

Role Description

The CSRM Physician is a leader in pharmacovigilance and is responsible for the overall clinical risk management and safety surveillance of assigned investigational and marketed products. As chairs of the Risk Management Safety Team, CSRM physicians lead the development and maintenance of risk management and pharmacovigilance plans.

• Engage directly in product development activities via core membership on Product Development Teams and chairmanship of the Risk Management and Safety Team, and other related sub-team participation, for assigned products.
• Partner with clinical development to ensure that clinical programs will support robust safety assessment of investigational compounds.
• Work with Clinical Research to develop the benefit-risk evaluation in aggregate safety reports.
• Collaborate closely with cross-functional team members including those from clinical development, epidemiology, regulatory affairs, statistics, and manufacturing.
• Manage safety topics under evaluation to ensure efforts are aligned to meet global pharmacovigilance and risk management strategies for assigned products.
• Evaluate safety data from multiple sources, ensuring completeness of safety information in company core data sheets.
• Accountable for scientific strategy for safety-related documents (e.g., CTD components, Risk Management Plans, and Periodic Safety Update Reports).
• Ensure that the safety sections of Company product circulars are medically and scientifically appropriate.
• Responsible for safety surveillance activities for assigned products, including aggregate clinical trial data analysis and post-approval safety signaling reviews.
• Collaborate with CSRM Associate in the oversight of safety surveillance activities for assigned products.
• Contribute to recommendations for pharmacovigilance actions and develop Risk Management Plans, pharmacovigilance strategies, and risk minimization activities.
• Oversee the review and approval of product labeling files stored in the safety database.
• Prepare safety summaries and analyses of safety-related data for regulatory documents and aggregate reports.
• Participate in the development, implementation, and evaluation of standards, processes, metrics, and other department initiatives.

Qualifications

• Required: MD, DO, or equivalent
• Preferred: Board Certification

Requirements

• Minimum of 3 years clinical experience following post-graduate medical training or other relevant clinical experience.
• Prior experience in drug development (may include clinical development and/or regulatory).
• Experience in clinical safety, pharmacovigilance, and/or risk management.
• Demonstrated organizational leadership skills, preferably in the employment areas noted above.
• Excellent communication, writing, and analytic skills.

Benefits

• Comprehensive package of benefits including medical, dental, vision healthcare, and other insurance benefits (for employee and family).
• Retirement benefits, including 401(k).
• Paid holidays, vacation, and compassionate and sick days.