We are currently seeking a head of drug safety & pharmacovigilance to implement, execute and manage pharmacovigilance and risk management activities as part of the Company’s product development and commercialization strategy. This role is responsible for product safety strategy and pharmacovigilance, medical safety, risk management systems and activities. This role interfaces across all functional areas and is responsible for the establishment of pharmacovigilance procedures and processes for the development of product safety profile and oversight for all pharmacovigilance operational activities to ensure patient safety and compliance to regulatory requirements.

Duties and Responsibilities:

• Leads safety and pharmacovigilance activities for all company products in development including ICSR review, periodic safety surveillance activities, safety issue work-up, preparation of DSUR, and authoring relevant safety sections of clinical documents including protocols, IB, ICFs, CSRs etc.
• Provides oversight of safety vendors to ensure all pharmacovigilance commitments are delivered and timelines are followed and manages the budget for these activities.
• Collaborates closely with both internal and external stakeholders to ensure effective and timely monitoring, oversight, and communication, and risk mitigation of emerging safety signals.
• Evaluates and interprets safety data from pre-clinical studies, clinical studies, literature, etc. to inform/predict safety profile of drugs in development.
• Provides benefit/risk assessment on potential safety signals as needed.
• Prepares, runs and documents internal Safety Review Committees for all products, and leads the identification and assessment of safety signals and development of action plans as needed.
• Works with vendors to prepare/review all safety relevant operational documents, including SMP, SAE reconciliation plan, medical monitoring plan, data management plan, etc.
• Collaborates with business partners on development of PVA and ensures compliance with PVAs.
• Provides safety related due diligence for business development opportunities.
• Participates in development of pharmacovigilance plans / risk management strategies, etc.
• Establishes department structure, processes, and procedures, responsible for hiring / training new employees.

Qualifications and Skills:

• Degree in medical field or pharmacology required (for example, RN, MSc, PharmD, or MD). Clinical experience strongly preferred.
• 10+ years of industry experience in safety and pharmacovigilance including increasing responsibility in administrative and management roles.
• Expertise in safety signal detection and management, clinical safety assessments of individual cases and aggregate data, case processing and routine pharmacovigilance practices, including interactions with Regulatory Authorities.
• Expert knowledge and familiarity with FDA regulations, EU GVP and ICH standards for development and marketing of pharmaceutical products, Good Clinical Practice (GCP) requirements, and other applicable regulatory standards.
• Experience with vender oversight and management, including budgeting.

Other Information:

NiKang currently anticipates the annual base salary range for this Senior Director-level role is estimated to be from $265,000 to $290,000. Our job titles span more than one career level. The actual title for this role and final salary amount offered to a successful candidate may be higher or lower than the estimated range and will depend on several factors that include, but are not limited to, the geographic location of the candidate, the type and length of applicable experience, education, and other relevant factors. In addition to base salary, the hired applicant for this position will be eligible to receive an annual discretionary bonus and potential equity awards based on factors such as individual and organizational performance. NiKang offers a comprehensive benefit plan to eligible employees, including eligibility to participate in a company-sponsored 401(k) program, Paid Time Off benefits, eligibility for medical, dental, vision benefits, flexible benefits, short-term disability and life insurance benefits. NiKang reserves the right to amend, modify, or terminate its compensation and benefit programs at its sole discretion.

The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.