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:
In the performance of his duties, the Employee is responsible for the following areas in Belgium, Netherlands and Luxembourg:
Regulatory affairs:
1. 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
2. Relationships with the Health competent authorities
3. Ensure mandatory submissions to local Health authorities and maintain health database up to date (e-compendium, etc.) in a timely manner
4. Implementation of change control after regulatory approvals (marketing authorization, variations, risk management plan, etc.)
5. Steer early access programs management
6. Marketing monitoring (report to health authority on initial marketing date, prohibition or restriction decisions or any information that can influence the benefit / risk assessment)
7. Organization of local training process
8. Pharmaceutical documentation archiving management
9. Oversee Regulatory intelligence
10. Risk management approach (document management, complaints, audits, continuous improvement, premises, suppliers, shortages, etc.) and business continuity plan implementation
11. Monitoring of local pharmaceutical vendors
Medical information management:
12. Collaboration with the Medical information department (data management, review of standard responses, access to literature database)
13. Collection, registration and follow-up of responses to medical information requests
14. Reconciliation of shared medical information data
15. Monitoring of KPI
16. Providing the information i.f.o. MAH (e.g.: questions from patients, professionals,…)
Promotional and medical material review:
17. Collaboration with the commercial and medical team in the review and approval of the promotional and non-promotional material
18. Submission to Health authority and Institution of promotional material, if applicable
19. Logistical management of material with traceability (withdrawal, recall, archiving, etc.)
20. Establishing an appropriate internal procedure for approving advertising and various promotional activities
21. Ensure local field team is using appropriate material
22. 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:
23. Organization of trainings on pharmaceutical and compliance processes
24. Review of training material for commercial and medical teams
25. Evaluation of skills
26. Overseeing the training of medicinal representatives visiting doctors, pharmacists, and other healthcare professionals.
Quality assurance / distribution / supply chain:
27. Set up/follow-up of audits for local pharmaceutical activities
28. Participation in audits and inspections by authorities (FAMHP-FAGG-AFMPS, etc.)
29. Follow-up of Batch release for distribution and tracking/traceability of batches distributed locally
30. Batch recall monitoring with marketing authorization holder, Health authority and distributor
31. Shortage monitoring with Health authority
32. Quality complaints management
33. Standard Operating Procedures (SOPs) creation, implementation and maintenance
34. Quality compliance monitoring
35. Deviations monitoring
36. Change Control initiation and management as applicable
37. KPI monitoring (definition, collection and analysis of KPI for major pharmaceutical activities)
Drug safety management:
38. Implementation of the local pharmacovigilance process
39. Designation as local Qualified Person responsible for Pharmacovigilance
40. Interaction with European Qualified Person responsible for Pharmacovigilance (EEA QPPV) and Global Patient Safety team
41. Local Procedures and data management
42. Report to Competent authorities
43. Steer national assessment and approval in Belgium, Netherlands and Luxembourg for EU driven additional Risk Minimization Materials
44. Oversee the collection, registration, report and follow-up of adverse events, activities outsourced with service provider deputy local contact person for Pharmacovigilance
45. 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
46. Local Signal detection
47. Oversee Periodic Safety Update Report (PSUR) and PSMF updates
48. Ensure reconciliation of shared PV data
49. Monitor key performance indicators (KPI)
Prevention advisor role:
50. Fulfill the role of the employer designated Prevention advisor in line with the Belgium regulation
51. Overview the legally required, repeated risk analysis to advise the employer on preventive protective measures
Lead BeNeLux Compliance management:
52. Monitoring of local law about anti-bribery, transparency and compliance of interaction with HCPs, HCOs, and POs
53. Participation to legal review of agreements with healthcare professionals, hospitals, organizations, etc.
54. Participation to Personal data protection organization
55. Oversee submission of HCPs / HCOs sponsorships to local authorities (MDEON)
56. Oversee Transparency disclosure
57. 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
58. Ensuring compliance with the regulations on “premiums or advantages”
RD 07/04/1995 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:
59. A minimum of 10 years of pharmaceutical industry/biotech in regulatory affairs in Belgium (and Lux is a plus)
60. Certified Prevention Adviser Level III
61. Fluent in English, French or Dutch (trilingual is a plus)
62. Oncology market experience strongly preferred
63. Experience in working in a dynamic, lean environment is preferred
64. In depth knowledge and understanding of the regulatory system and challenges and opportunities
65. Hands-on experience and successful track record in contacts with regulatory authorities
66. Demonstrated success and experience supporting product pre-launch, launch and post-launch
67. Demonstrate deep scientific knowledge
68. Demonstrated ability to translate strategic insights into practical, well-designed processes
69. Demonstrated ability to operate in matrix environment
70. Demonstrated cross-functional collaboration and out-of-the-box thinking
71. Agile, strategic thinking and ability to develop innovative global reimbursement/pricing strategies
72. Highly skilled in influencing cross-functional teams, including interfacing with key internal and external stakeholders and with scientific and commercial teams
73. 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
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.
74. Fosters Teamwork
75. Provides and Solicits Honest and Actionable Feedback
76. Self-Awareness
77. Acts Inclusively
78. Demonstrates Initiative
79. Entrepreneurial Mindset
80. Continuous Learning
81. Embraces Change
82. Results-Oriented
83. Analytical Thinking/Data Analysis
84. Financial Excellence
85. Communicates with Clarity