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.
Qualified Person Responsible for Information and Publicity (QP RIP), Local contact Person PV, Prevention Advisor, Belgium & Luxembourg.
General Description
The Pharmaceutical Affairs Associate Director acts as the Qualified Person Responsible for Information and Publicity (QP RIP) and is responsible for medical information and publicity in Belgium and Luxembourg.
As Pharmaceutical affairs Associate Director, he (she) also steers locally the quality, regulatory and compliance activities within the affiliate and in collaboration with EU departments in accordance with Belgian, Dutch and Luxembourg laws and regulations (Good Distribution Practices, Good Pharmacovigilance Practices, Good Manufacturing Practices) and company requirements.
He (she) is the Local contact Person for Pharmacovigilance (LPPV) for both Belgium and Luxembourg national competent authorities.
He (she) also fulfills the role of the Prevention advisor, provides ad hoc PMO, and endorses the transversal activities carried out by the marketing, medical, compliance, distribution, supply chain, pharmacovigilance, HR and market access EU and BeLux departments.
He/she organizes a backing‑up for the QP RIP role as applicable.
Essential Functions Of The Job
Regulatory Affairs
Fulfill the role of the assigned Qualified Person Responsible for Information and Publicity (QP RIP)
Evaluation and final approval of abridged product information (abbreviated SPC)
Review of Medical advertising and medical information processes
Relationships with the Health competent authorities
Ensure mandatory submissions to local Health authorities and maintain health database up to date (e-compendium, etc.) in a timely manner
Implementation of change control after regulatory approvals (marketing authorization, variations, risk management plan, etc.)
Steer early access programs management
Marketing monitoring (report to health authority on initial marketing date, prohibition or restriction decisions or any information that can influence the benefit / risk assessment)
Organization of local training process
Pharmaceutical documentation archiving management
Oversee Regulatory intelligence
Risk management approach (document management, complaints, audits, continuous improvement, premises, suppliers, shortages, etc.) and business continuity plan implementation
Monitoring of local pharmaceutical vendors
Medical Information Management
Collaboration with the Medical information department (data management, review of standard responses, access to literature database)
Collection, registration and follow‑up of responses to medical information requests
Reconciliation of shared medical information data
Monitoring of KPI
Providing the information i.f.o. MAH (e.g.: questions from patients, professionals,…)
Promotional And Medical Material Review
Collaboration with the commercial and medical team in the review and approval of the promotional and non‑promotional material
Submission to Health authority and Institution of promotional material, if applicable
Logistical management of material with traceability (withdrawal, recall, archiving, etc.)
Establishing an appropriate internal procedure for approving advertising and various promotional activities
Ensure local field team is using appropriate material
Act as scientific service person responsible for providing information about the medicinal products related to advertising (Article 95 of the Dutch Medicines Act)
Training Material
Organization of trainings on pharmaceutical and compliance processes
Review of training material for commercial and medical teams
Evaluation of skills
Overseeing the training of medicinal representatives visiting doctors, pharmacists, and other healthcare professionals.
Quality Assurance / Distribution / Supply Chain
Set up/follow‑up of audits for local pharmaceutical activities
Participation in audits and inspections by authorities (FAMHP-FAGG-AFMPS, etc.)
Follow‑up of Batch release for distribution and tracking/traceability of batches distributed locally
Batch recall monitoring with marketing authorization holder, Health authority and distributor
Shortage monitoring with Health authority
Quality complaints management
Standard Operating Procedures (SOPs) creation, implementation and maintenance
Quality compliance monitoring
Deviations monitoring
Change Control initiation and management as applicable
KPI monitoring (definition, collection and analysis of KPI for major pharmaceutical activities)
Drug Safety Management
Implementation of the local pharmacovigilance process
Designation as local Qualified Person responsible for Pharmacovigilance
Interaction with European Qualified Person responsible for Pharmacovigilance (EEA QPPV) and Global Patient Safety team
Local Procedures and data management
Report to Competent authorities
Steer national assessment and approval in Belgium, Netherlands and Luxembourg for EU driven additional Risk Minimization Materials
Oversee the collection, registration, report and follow‑up of adverse events, activities outsourced with service provider deputy local contact person for Pharmacovigilance
Oversee and follow‑up local scientific and medical literature screening for pharmacovigilance relevant information, activities outsourced with service provider deputy local contact person for Pharmacovigilance
Local Signal detection
Oversee Periodic Safety Update Report (PSUR) and PSMF updates
Ensure reconciliation of shared PV data
Monitor key performance indicators (KPI)
Prevention Advisor Role
Fulfill the role of the employer designated Prevention advisor in line with the Belgium regulation
Overview the legally required, repeated risk analysis to advise the employer on preventive protective measures
Lead BeNeLux Compliance Management
Monitoring of local law about anti‑bribery, transparency and compliance of interaction with HCPs, HCOs, and POs
Participation to legal review of agreements with healthcare professionals, hospitals, organizations, etc.
Participation to Personal data protection organization
Oversee submission of HCPs / HCOs sponsorships to local authorities (MDEON)
Oversee Transparency disclosure
Steering processes and overseeing compliance with the local regulation on “medical samples”
Belgian RD 11/01/1993 setting the conditions in which the delivery of medicines for human use in the form of samples can be organized
Ensuring compliance with the regulations on “premiums or advantages”
RD 07/04/1955 on the information and publicity concerning human medicines, articles 13
4, 15 and Law of 25/03/1964 on Medicines, article 10
In Luxembourg the responsibilities are similar to the ones in BE. A great proportion of the responsibilities in NL are similar to the ones in BE.
Qualifications
A minimum of 10 years of pharmaceutical industry/biotech in regulatory affairs in Belgium (and Lux is a plus)
Certified Prevention Adviser Level III
Fluent in English, French or Dutch (trilingual is a plus)
Oncology market experience strongly preferred
Experience in working in a dynamic, lean environment is preferred
In depth knowledge and understanding of the regulatory system and challenges and opportunities
Hands‑on experience and successful track record in contacts with regulatory authorities
Demonstrated success and experience supporting product pre‑launch, launch and post‑launch
Demonstrate deep scientific knowledge
Demonstrated ability to translate strategic insights into practical, well‑designed processes
Demonstrated ability to operate in matrix environment
Demonstrated cross‑functional collaboration and out‑of‑the‑box thinking
Agile, strategic thinking and ability to develop innovative global reimbursement/pricing strategies
Highly skilled in influencing cross‑functional teams, including interfacing with key internal and external stakeholders and with scientific and commercial teams
Excellent interpersonal, oral and written communication skills, including ability to synthesize data and deliver a clear overview of market access strategy, opportunity and risks
Education Required
PharmD or PhD, or Bachelor of Science, Master’s in Science or Business
Computer Skills
Standard Computer Skills required
Travel
Approximately 20% of time
Competencies
Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit. Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management – Communicates changes and progress; Completes projects on time and budget.
Global Competencies
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. 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.
#J-18808-Ljbffr