This role will play a critical role in the development of our client’s products through management and implementation of effective vigilance, post-marketing surveillance (PMS) and trending systems to conform with global safety requirements/laws. This position works cross-functionally to generate solutions and implement process standards consistent with pharmaceutical and device industry best practices. This person is a strong problem solver and communicator with a solid understanding of global regulations and standards and will be responsible for the production and accuracy of PMS and Vigilance activities.
Works in close collaboration with cross-functional teams and counterparts in quality systems, regulatory affairs, clinical development, clinical operations, manufacturing, marketing and other functional areas to identify, evaluate, and communicate safety issues. May contribute relevant clinical safety input to new product design teams as needed
Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance
Safety surveillance for pharmaceutical / biological / device products
Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans
Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents
Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams
Lead write, review and provide input on technical documents
Demonstrated capabilities to be agile and nimble in a start-up organization.
Effective communication and a reputation for integrity and ethical behavior are critical.
Strong interpersonal skills, a flexible, collaborative, and team-oriented approach to problem-solving, and an ability to work in a fast-paced, rapidly changing environment.
10+ years of safety and pharmacovigilance experience. Experience in the aesthetic and dermatology areas is preferred.
Bias towards start-up experience in a fast-pace environment!
Strong analytical, problem solving mindset.
Enjoy the creative process - you’ll be working in constant collaboration.
Exceptional organizational skills and detail-oriented.
Strong written and verbal communicator with key decision makers.
Self-starter who is driven to address problems and produce solutions.