Senior Medical Director, Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee product safety surveillance and manage the evolving safety and benefit-risk profiles for designated products.

• Lead a cross-functional safety management team (SMT) for assigned products, responsible for continuous evaluation of benefit-risk profiles and associated actions throughout the product life cycle.

• Analyze safety data from multiple sources (e.g., pre-clinical, clinical trial data, post-marketing, literature) during the development process as well as after marketing for assigned products.

• Conduct signal detection activities, monitor, evaluate, interpret, and effectively manage and communicate safety information.

• Represent pharmacovigilance on cross-functional product/project teams, including reviewing safety sections of protocols, investigator brochures, informed consent forms, and other safety-related documents.

• Oversee the strategy and key elements of Risk Management documents (DRMPs, RMPs, REMS) and regulatory communications.

• Provide strategic direction and guidance to safety risk management scientists in the preparation of periodic reports for assigned products; ensure medical interpretation, review, and approval.

• Ensure the accurate representation of safety information in the Company Core Data Sheet, Investigator Brochure, and other labeling documents.

• Conduct medical reviews of all adverse event reports concerning seriousness, expectedness, and causality.

• Mentor, coach, and manage safety scientists involved in the surveillance activities for assigned products.

⛳️ Requirements

• MD or equivalent with 3-5 years of relevant clinical experience.

• At least 10 years of industry experience in Drug Safety/Pharmacovigilance with investigational and/or marketed products.

• Demonstrated expertise in safety data analysis, signal management, and benefit-risk assessment.

• Proficient in using safety databases (Argus, ArisG/LifeSphere Safety, or similar).

• Proven track record in developing and implementing drug safety strategies and risk management plans.

• Experience authoring or contributing to clinical study and regulatory submission documents.

• Familiarity with relevant local and global regulatory requirements and guidance documents.

• Capable of leading in a cross-functional environment and collaborating effectively with both internal and external partners in a dynamic setting.

• Strong oral and written communication skills.

• Highly motivated, self-driven, and reliable.

🏝️ Benefits

• Annual bonus opportunity.

• Medical coverage.

• Dental insurance.

• Vision care.

• Life and AD&D insurance.

• Short-term and long-term disability coverage.

• 401(K) plan with matching contributions.

• Stock options.

• Flexible non-accrual paid time off.

• Parental leave.