Associate Director, QPPV and Regional Lead

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where “BeiGene” or “BeOne” are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Reporting line: Country Manager, Serbia; dotted line to Senior Director, Quality Head, New Markets and Senior Director, International & PV Partnerships 

General Description:

This position will have a dual role and hold the responsibilities for Pharmacovigilance and Quality Assurance.

He/She will be responsible for patient safety within the country as the Local QPPV, including case safety reporting, periodic reports, legislation monitoring, literature surveillance, and local SOPs. He/She will help establish the local PV system in line with the Global Patient Safety strategy.

The incumbent will provide GMP/GDP expertise in Serbia, oversee the affiliate setup, commercial launch, and post-marketing quality activities. He/She will ensure compliance in the distribution of IMPs and commercial products for BeiGene (Serbia) and will oversee BeiGene (Serbia) document management which includes the Quality Management System.

Key Responsibilities

Local Safety Responsible

• Responsible for establishing the national PV system.
• Acts as the point of contact for all pharmacovigilance enquires at the country level; appointed as the local QPPV to the Medical and Medicines Device Agency of Serbia.
• Responsible for ongoing legislation monitoring, subsequent impact assessment and recommendations relating to operational updates/modification.
• Responsible for ICSR intake, translation (were necessary), follow-up and regulatory authority submission where applicable.
• Responsible for establishing and monitoring local & regional communication channels for the exchange of safety information; triages information appropriately across Global Patient Safety and interfacing teams
• Supports preparation and/or submission of periodic reports (PSURs, DSUR, Annual reports)
• Monitor the benefit risk profile of assigned portfolio and providing evaluation to the Global Safety Management Team (SMT), or relevant safety governance committee
• Monitors and communicates in a timely manner with GPS functions about local Risk Management Plans (RMP) and risk minimization activities relevant for the territory
• Maintains awareness of local activities such as, but not limited to, market research, patient support programs, investigator sponsored research, non-interventional studies, compassionate use programs and named patient supply
• Ensures PV training and its documentation for all staff at national levels as appropriate
• Monitors local BeOne sponsored websites and digital media
• Works with stakeholders to support business partners and vendors to ensure the maintenance of the PV system(s)
• Ensures the GVP compliance of the PV system, including but not limited to maintaining country specific SOPs, supporting GVP audits and inspections.

Quality Responsibilities

• Ensure that the affiliate Quality Management System complies with relevant national and international guidelines and internal policies/global standards/SOPs are met
• Collaborates with local Distributors in Serbia region (including Quality Agreement, support qualification, support audits)
• Act as single point of contact for Distributor/s in the assigned territory for quality activities
• Manages Quality Agreements, local QMS, Deviations, Temperature Excursions, Change Controls and CAPAs for the Serbian market
• Responsible for controlled documentation
• Actively contribute to establish and review Global Quality Standards to ensure compliance with local law requirements
• Oversee product complaint handling in Serbia
• Advise and support agreements (e.g. Quality Distribution, Service, Master, Collaboration) regarding content, implementation, review and updates.
• Support regulatory filings, as needed.

Other responsibilities

• Leads the development, maintenance and approval of country and/or regional SOPs, matrices and work instructions, in accordance with global and local regulation and company practices
•  Supports inspection-readiness activities; supports during Health Authorities inspections and internal audits

Education and Experience:

• MD, PharmD or DMD is a must
• 5+ years pharmaceutical or biotechnology industry experience
• Highly experienced in Serbian regulations and requirements, including extensive GDP, GMP, and GVP experience (5+ years)
• Knowledge of setting up QMS and PV system in Serbia (preferred)
• Experience working with Distributors or Logistic Providers (3PLs)
• Experience with regulatory compliance inspections
• Well connected with external industry associations in the territory

Other Skills and Qualifications:

• Excellent English verbal, written and interpersonal communication skills; attention to details
• Strong presentation skills
• Competency with safety databases and learning management systems (ArisG, Argus, Veeva, ComplianceWire)
• Strong Project Management Skill Set
• Highly skilled in working cross functionally
• Highly skilled in working independently, troubleshooting and problem solving
• Ability to work across regions

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

We are proud to be an equal opportunity employer and we value diversity. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.