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Associate Director, PV Scientist

Posted on Apr 6, 2021 by Karyopharm Therapeutics Inc.

West Newton, MA 02465
Immediate Start
Annual Salary

The Associate Director, PV Scientist leads the PV scientist group and supports the medical component of pharmacovigilance activities including surveillance activities providing scientific/clinical PV expertise with a focus on the identification, evaluation, and management of safety risks for Karyopharm products. This role will collaborate closely with the safety physician and cross-functional partners to evaluate and actively manage risks in accordance with global regulatory frameworks.

Mentor and support PV scientists in achieving departmental and organization goals
Hire, train and maintain well qualified PV scientists
Organize and perform independently or collaboratively as necessary, the relevant safety data analysis for Safety Management Team meeting; ensure adequate documentation of meeting minutes
Create and maintain an effective signal tracking process that fully documents signaling activities and can be used for regulatory inspection
Support other function teams for Karyopharm investigational products; serve as PV expert and liaise with Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, and Contract Research Organizations and other entities as needed
Provide oversight for the safety data analysis and manage PV Scientists
Provide leadership in the development, implementation, and maintenance of robust procedures for the planning, preparation, and submission of high-quality safety reports
Contribute to health authority and other safety related query responses
Support study teams for Karyopharm investigational products; serve as PV expert and liaise with Clinical Operations, and clinical development
Demonstrate knowledge and ensure compliance with current and applicable global PV regulations and guidelines (eg, CIOMS, EMA, FDA, ICH, etc.)
Ensure compliance with Karyopharm and PVG & Risk Management policies and procedures
Prepares aggregate safety reports (eg DSURs, PSURs), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks
Plans and executes literature surveillance
Support PV activities as needed


Advanced healthcare degree required
Minimum 6 years' pharmacovigilance or relevant experience, including at least 4 years' concentration on aggregate safety report writing
Thorough understanding of the drug development process and context applicable to safety surveillance activities
Knowledge of MedDRA terminology and its application
Excellent written and oral communication skills, strong attention to detail, and high performance standards for quality
Ability to analyze, interpret, and summarize complex clinical and medical literature data
Ability to prioritize and complete work in a resourceful, self-sufficient manner while maintaining a strong mentality
Displays ability to understand established procedures and communicate those procedures to others
Exhibits comprehension of industry practices and regulations for drug development and pharmacovigilance
Demonstrates awareness of related medical disciplines and an understanding of general concepts and some experiential detail within those areas
Possesses computer skills to support use of electronic systems and development of writing deliverables

Reference: 1152693628

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