Executive Director, Safety Operations

BeiGene

6d•$285,800 - $365,800•Hybrid

About The Position

As part of the Global Patient Safety (GPS) leadership team, this role is to ensure end-to-end execution, quality and continuous improvement of global safety operations activities; oversee effective collection, processing, assessment and reporting of ICSRs against global standards; oversee safety operations activities in clinical trials, as well as China PV activities, oversee safety systems and reporting activities and actively influence GPS’ operational technology strategy and provide broad and deep technical knowledge. This role supports and contributes to internal GPS department development and liaises cross-functionally to execute on PV responsibilities.

Requirements

MD, PharmD., RN plus higher degree or international equivalent, or the equivalent combination of relevant education or professional experience
Mastery of global safety regulatory requirements
Fifteen (15) years relevant experience, including training
Ten (10) years drug safety experience
Proficiency in safety report processing & operational systems
Proficiency of signal recognition, statistical techniques & trials methods & outputs
Previous management experience
Process and systems management experience preferred
Clinical experience preferred
Proficiency with Microsoft office
Proficiency in technical safety systems including ARGUS and data convention

Responsibilities

Oversee development & systematic improvement of safety data collection methods
Ensure that management, flow, & distribution of safety data is globally consistent
Oversee data convention standards within the database
Ensure ICSR submissions to all destinations in compliance with regulation and PV agreements
Ensure appropriate representation of SAE data for inclusion in safety-related reports in clinical trials
Ensure compliance of safety operations activities in clinical trials
Ensure effective liaison with internal & external stakeholders to operationalize and optimize process related to safety reporting including such as Trail Master File (TMF) plan and Safety Management Operation plan
Supervise China PV responsible person for MAH and DRE, ensuring that the operation and continuous improvement of the pharmacovigilance system to meet the requirements of relevant laws and regulations in China.
Ensure compliance of adverse drug reactions monitoring and reporting
Oversee the identification, assessment and control of drug safety risks and ensure the effective implementation of risk control measures
Be responsible for the management of drug safety information communication and ensure timely and effective communication
Ensure smooth communication channels within the internal stakeholders and business partners, as well as the drug regulatory authorities and the drug adverse reaction monitoring authorities
Oversee Safety database, Safety Reporting, and other associated safety gateways and data repositories
Support technical activities and documentation for all safety systems working with other technology teams
Oversee development and implementation of PV technology strategies and projects
Enhance PV technology footprint within GPS in collaboration with cross departments and in alignment with organizational objectives
Develop budget and investment strategies for new technology capabilities to support PV
Create resource requirement projections for safety operations
Recruit, retain, develop, and mentor safety operations staff
Create, sign off and maintain policies, guidelines, and SOPs from safety operations perspective
Contribute to Compliance Forum and Process & Standards Forum
Contribute to audits and inspections
Support the development & realization of the GPS department’s vision and long-range plan
Participate in the review of pharmacovigilance agreements and oversee PV agreement execution from safety operations perspective
Support outsourcing / vendor selection strategies and relationships from safety operations perspective
As Function head, leads GPS Safety Operations Team: Global ICSR Management, Global ICSR Submission, Trial Safety Operations, China Post Marketing Safety Operations, Safety Systems and Supporting