Manager - Pharmacovigilance Scientist ()

We are seeking a dynamic and motivated individual for the role of Manager, Pharmacovigilance Scientist. This role is critical in overseeing pharmacovigilance (PV) activities for assigned programs, ensuring patient safety, and collaborating with cross-functional teams in Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management, and Biostatistics.
 

Responsibilities:

• Collaborate with PV and cross-functional teams to manage the benefit/risk profile of assigned products, ensuring patient safety.
• Assist with signal detection activities, including data gathering, validation, and evaluation.
• Oversee literature monitoring (with vendor support) and ensure integration of relevant sources into signal detection.
• Participate in and lead aggregate safety report activities, including data analysis, compilation, and writing of assigned sections (with vendor support).
• Prepare agendas, data, slides, and minutes for cross-functional Safety Management Team meetings in collaboration with the Program Safety Lead.
• Represent PV Operations on cross-functional program and project teams and support PV Medical Safety activities as needed.
• Coordinate responses to ad hoc safety inquiries from regulatory authorities, sites, or healthcare professionals, including compiling data, analyzing results, and submitting responses.
• Contribute to inspection readiness and operational improvements within the department and cross-functional teams.
• Serve as a subject matter expert in pharmacovigilance, including both operational and medical aspects, within the assigned program.
• Collaborate effectively with external partners in PV-related activities.

Requirements:

• Bachelor’s degree in a healthcare or life sciences-related field.
• Minimum of 3 years of experience in pharmacovigilance within the pharmaceutical industry.
• Strong knowledge of FDA, EU regulations, and GCP/GVP/ICH safety guidelines for investigational and marketed products.
• Ability to work independently, set priorities across multiple projects, and complete tasks with minimal supervision.
• Excellent interpersonal skills, with the ability to work collaboratively in a multidisciplinary environment.
• Strong communication skills, with fluency in written and spoken English.

Preferred Qualifications:

• Master’s degree or other advanced degrees in a healthcare or life sciences-related field.
• Prior experience in oncology and/or neurology.
• Experience in both investigational and marketed products pharmacovigilance.

This is a full time position