Other Locations:UK- Stockley Park
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
- To lead the Drug Safety & Risk Management team of the Celgene UK/Ireland affiliate.
- To ensure excellent regulatory compliance and credibility
- To ensure proactive pharmacovigilance across the product lifecycle for all Celgene products
- To provide excellent safety support to product development, commercialization and operations post marketing
- Support development of strategic plans for safety differentiation of Celgene product.
- Ensure appropriate compliance with Risk Management activities, and data sharing as required within the affiliate, maintaining oversight of data quality.
Role and Responsibilities
The Senior Director, Head of Drug Safety & Risk Management Celgene UK/IRL is
- A role based in Celgene UK/IRL office.
Reports (at a minimum) to
- Executive Director, EEA QPPV Global Drug Safety & Risk Management (GDSRM).
- Reports in matrix to the Medical Director UK/IRL.
Acts as a single pharmacovigilance and risk management point of contact for RAs.
- Sustaining regulatory credibility through delivery of outstanding quality and compliance standards and process excellence in all Affiliate Drug Safety and Risk Management (RM) responsibilities.
- Providing key subject matter expertise for Drug Safety and Risk Management in the affiliate.
- Fulfilling GDSRM Ambassadorial role within the Affiliate and deliver resolute local leadership in support of the Mission, Vision and Values in accordance with applicable policies, practices and procedures.
- Developing effective working partnerships in collaboration with key Affiliate Stakeholders, GDSRM Global/International in support of Celgene’s Drug Safety and Risk Management System.
- Contributing to GDSRM continuous process improvement and leverage of innovation to drive technical and operational excellence in support of higher order Drug Safety and Risk Management throughout Celgene’s GDSRM Network
- Ensuring Celgene UK/IRL practices proactive pharmacovigilance for all its products.
- Ensuring appropriate procedures and resource enabling pharmacovigilance, risk assessment, risk communication and risk management.
- Ensuring compliance of local/global regulatory and of Celgene company policy.
- Leading change initiatives within GDSRM or with other department and HQ.
- Recruitment, hiring, retention and development of Pharmacovigilance and risk management staff.
- Overseeing of Pharmacovigilance department budget, in accordance to GDSRM International practices.
List of Key Accountabilities
Case Management and Processing
- Effective workload prioritization and triaging of ICSRs in order to sustain excellence in regulatory expedited reporting compliance.
- Reconciliations from multiple sources external and internal
- ICSR Management:
- Clinical ICSR management, as per GDSRM processes
- Post Marketing ICSR Management, as per GDSRM processes
- Translations for each activity, if applicable
- Ensure submission of special situations in accordance with regulatory commitments
- Support Global Drug Safety & Risk Management by leading locally the implementation and maintenance of local Risk Minimisation Programmes (as per the product Risk Management Plan).
- Lead Risk Minimisation in Affiliate led Organised Data Collection Schemes to support GDSRM’s oversight, including but not limited to:
- Risk Minimisation Programme compliance and effectiveness measures, when applicable
- Other projects, such as PASS and PAES where applicable e.g. provision of Additional Educational Materials for Risk Minimisation.
- Pre-approval Access (e.g. Compassionate Use, Named Patient Programs) e.g. implementation and maintenance of applicable Risk Minimisation Programmes
Translations, if applicable
Management and oversight of UK/IRL specific pharmacovigilance activities
- Lead Pharmacovigilance (PV) in Affiliate led Organised Data Collection Schemes to support GDSRM’s oversight, including but not limited to:
- Non interventional studies
- Patient Support Programs
- Market Research Surveys (review of surveys/questionnaires and protocols, contracts and vendor training)
- Oversee the development, implementation and enforcement of Post-marketing - Surveillance/Studies, including data collection, analysis and summary of results.
- Pre-approval access (e.g. Compassionate Use, Named Patient Programs)
- Interventional & non-interventional IIT protocols, CRFs, ICFs and contracts review
- IITs Sponsors/CROs training
- Provide PV input/safety reporting training to Investigator Meetings including IITs and Celgene Sponsored (if applicable)
- Reconciliation of DSURs/ASRs (periodic aggregate reports)
PV Compliance and Quality
- Oversight of Affiliate adherence to Compliance and Quality Standards as defined by GDSRM.
- Implement and comply with relevant GDSRM policies and procedures.
- Ensure compliance with regulatory PV requirements and with Celgene’s internal requirements.
- Support continuous Inspection and Audit readiness including leading successful and timely responses to CAPAs.
- Issue management: timely escalation of potential compliance issues and delivery of appropriate CAPAs in collaboration with relevant GDSRM /GDSRM EMEA/APAC Functions and EU QPPV.
- Maintain awareness and ensure accuracy of local content contained within the Global Pharmacovigilance System Master File.
- Ensure Third Party Vendors conducting activities of the Pharmacovigilance System under go appropriate review and approval.
Regulatory Authority and third-parties Interactions
- Support QPPV interactions (fulfill role of National Contact Point for Pharmacovigilance for National Competent Authorities in accordance with 2010/84 where applicable)
- Escalation to GDSRM of enquiries from regulatory agencies and Healthcare Professionals on safety and Risk Minimisation questions for marketed products
- Local Drug Safety input into DHPC Letters (where applicable)
- Local Drug Safety input to Prescribing Information maintenance and update
- Coordinate approval/notification process for Additional Educational Materials per the product Risk Management Plan (where applicable)
- Support and Oversight of timely submission of Safety document (i.e RMPs, PSURs, DSURs) to ensure compliance to national regulations, if applicable.
- Contribute to establish and maintain good relationship with patient advocacy groups.
Routine Pharmacovigilance Activities
- Provide Adverse Event and Risk Minimisation Programme Training to local staff/third parties
- Support and coordinate Product Quality Complaint interactions or process PQCs (where applicable)
- Support and coordinate Medical information interactions or process safety related inquiries
- Local legislation review and local gap analysis
- Local literature review (where applicable)
- AE Reconciliation with stakeholders
- Standards development & maintenance
- Review Pharmacovigilance Agreements and ensure there is appropriate PV agreements with local Business Partners
- Ensure Business continuity
- Maintain awareness of local Pharmacovigilance regulations
Continuous Process Improvement
- Support GDSRM deployment and conduct of local Quality and Compliance initiatives
- Support Delivery of GDSRM EMEA/APAC Goals as defined in performance documents
- Support continuous efficiency gains through identification of opportunities for process innovation and operational excellence
- Maintain awareness of metrics and drive metrics based approach to productivity and performance management in relation to defined Key Performance Indicators presented in GDSRM Safety Operations outputs and affiliate goals.
- Management of Drug Safety and Risk Management personnel to ensure objectives are met
- Support Training and Development for Drug Safety and Risk Management personnel
- Support talent acquisition and development in accordance with GDSRM defined standards
- Support annual GDSRM resource planning
Budget Management on Behalf of GDSRM
- Reinforce the GDSRM Mission, Vision and Value & Support GDSRM Oversight of Celgene’s Pharmacovigilance System
- Provide regular feedback to the Medical or country Leadership with respect to Metrics on Affiliate Pharmacovigilance Process and Activity and Compliance and trending analysis on safety data
- Support safety data and Risk Minimisation requests from Affiliate stakeholders through appropriate GDSRM escalation process
- Provide Pharmacovigilance expertise support to Affiliate Functions as required
- Communicate as required GDSRM assessment of changes in Benefit: Risk evaluation for marketed products to Affiliate stakeholders
- Contribute to GDSRM International initiatives & projects as required
- Be a member of the Local Medical Leadership Team (MLT)
- Support GDSRM ability to create & maintain a single, unified product level perspective on products' safety profiles from development to marketing
- Demonstrates character
- Develops talent
- Inspires & motivates
- Leads change
- Achieves results
Skills and Knowledge Requirements
- Scientific/Pharmacy/MD degree or equivalent
- Solid Pharmacovigilance experience or equivalent
- Line management experience
- Excellent knowledge of applicable national Pharmacovigilance legislation
- Broad appreciation of global regulatory requirements for Pharmacovigilance
- Proficiency in technical safety systems including IRT and ARISg
- Computer and database skills
- Good interpersonal and people management skills
- Good written and verbal communication skills
- Project Management skills: planning, organizational and time management skills
- Excellent at priority setting
- Thorough appreciation of the development and utilization of performance and process metrics
- Attention to detail
- Good analytical and diagnostic skills
- Commitment to follow Standard Operating Procedures
- Ability to demonstrate pro-activity
- Work independently and as part of a team
- Strong identification with Celgene’s values