JOB TITLE: Pharmacovigilance (PV)， Senior Director
EMPLOYER: Brii Biosciences
DEPARTMENT: China Clinical Development
JOB LOCATION: Beijing, China
REPORTS TO: CMO
EFFECTIVE DATE: 7/31/2019 or earlier
Job Purpose: The success candidate is to set safety strategy and responsible for the continued safety assessment, evaluation and risk management throughout various stages of clinical development, to predict and manage safety profile of compounds. Through identifying the need for update to reference safety information, the candidate drives proactive implementation of safety risk management initiatives in accordance with regulatory requirements. Responsibilities also include consistent communication of safety topics across all regulatory safety documents, proactive evaluation of clinical implications of safety data from clinical studies, literature and other information sources in order to predict and establish the safety profile of compounds, including employing expert groups and methodologies, modelling and simulation to manage the risk to patients.
DUTIES AND RESPONSIBILITIES:
Responsible for the design and implementation of PV strategy at company level and at compound level.
Review and analyze patient safety data from clinical trials; identify and investigate safety signals; manage and balance ongoing benefit and risk profile.
Accountable for all PV activities associated with filing and approval of clinical and marketing applications;
Ensure the accurate and timely completion and reporting of periodic and expedited safety reports, in compliance with internal time frames and time frames dictated by regulatory authorities;
Manage safety surveillance and data collection, in cooperation with a PV vendor, of current trials or real-world use for safety signaling; identify and investigate safety signals; provide patient-level narratives and adjudication.
Provides oversight and review of vendor activities. Oversight activities include monitoring compliance, effective communication and implementation of corrective and preventive actions, as needed.
Conduct analysis of safety data. Ensure adequacy of recording, summarizing, and handling of adverse events for investigational products including decisions on seriousness, expectedness, and causality.
Contribute to the development and implementation of risk minimization action plans.
Provide leadership on clinical safety content of marketing applications (e.g. NDA/MAA Clinical Safety Summary and Risk Management Plan).
Accountable and responsible for designing and executing strategy supporting medical review of ICSRs from all sources.
Responsible for responses to inquiries from regulatory authorities or HCPs on safety issues.
Work with clinical programs as medical advisor
Provide safety strategic leadership for clinical development programs/program teams; integrate the safety scientific component to build a strategic framework for clinical development plans.
Represent Drug Safety and Risk Management at internal and external meetings including business partners, the medical community as well with global regulatory authorities.
Maintain PV quality and develop/update PV SOPs/training programs as necessary.
Responsible for managing cross-functional activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across clinical trials.
Maintains knowledge of adverse event reporting process and safety system and contributes to the development; improves and standardizes new processes and methods.
Medical degree (MD)
Minimum 10 years in pharmaceutical industry (clinical research, pharmacovigilance, or medical affairs) or equivalent with a minimum 5 years in direct pharmacovigilance and/or drug safety.
Previous experience reviewing and/or contributing to PBRERs, DSURs, PADERs, and other safety surveillance reports.
PV Vendor management experience is a plus.
Knowledge of NMPA, FDA, ICH, EU Regulations and Requirements for Pharmacovigilance.
ARISg, Argus or other Safety Database experience
Excellent written and verbal communication skills in Chinese and English
The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.