Senior Principal Scientist, Drug Safety

This is a fully remote position, open to applicants in New Jersey, +1 more state.

📋 Description

• Lead the overall clinical risk management and safety surveillance for both investigational and marketed products.

• Chair the Risk Management Safety Teams and spearhead the creation and upkeep of risk management and pharmacovigilance plans.

• Engage in Product Development Teams, as well as internal and joint internal/external research teams, along with related sub-teams.

• Collaborate with clinical development and clinical research to facilitate thorough safety assessments and benefit-risk evaluations.

• Work alongside clinical development, epidemiology, regulatory affairs, statistics, and manufacturing teams regarding safety matters.

• Assess safety data derived from clinical trials, literature, and post-approval usage.

• Ensure the accuracy and completeness of safety information in company core data sheets.

• Formulate scientific strategies for safety-related documents, such as CTD components, Risk Management Plans, and Periodic Safety Update Reports.

• Verify that safety sections of product circulars are both medically and scientifically sound.

• Conduct analyses of aggregate clinical trial data and reviews of post-approval safety signals.

• Supervise safety surveillance activities in collaboration with the CSRM Associate.

• Recommend actions related to pharmacovigilance, labeling modifications, risk management plans, and risk minimization strategies.

• Review and authorize product labeling files in the safety database utilizing MedDRA knowledge.

• Prepare safety summaries and analyses for regulatory documents, aggregate reports, and regulatory submissions.

• Oversee CSRM medical associates in safety data analysis and regulatory document authoring as required.

• Contribute to the development, implementation, and assessment of departmental standards, processes, metrics, and initiatives.

⛳️ Requirements

• MD, DO, or an equivalent qualification is required.

• A minimum of 3 years of clinical experience following post-graduate medical training or other relevant clinical experience is necessary.

• Previous experience in drug development, encompassing clinical development and/or regulatory experience is essential.

• Experience in clinical safety, pharmacovigilance, and/or risk management is required.

• Proven organizational leadership abilities, preferably in the specified employment areas.

• Exceptional communication, writing, and analytical skills are necessary.

• Familiarity with Clinical Development, Clinical Risk Management, Clinical Safety, Clinical Training, Drug Development, Drug Safety Surveillance, Pharmacovigilance, Regulatory Documents, Risk Management, and Safety Assessment Reports is needed.

• Board Certification is preferred.

• Must be a resident of the US or Puerto Rico.

• Visa sponsorship is not available.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical, dental, and vision healthcare plans.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate and sick leave days.

• Remote work arrangements.

• Relocation assistance is not provided.