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Drug Safety and Risk Management Senior Specialist (6 to 12 months) United Kingdom,  


Posted on : 21 March 2017

Project Description

Req #: 17000278_1 Location: Hillingdon, England UK Job Category: Regulatory Affairs Work Location: Stockley Park, UK 1 Longwalk Road Stockley Park Hillingdon UB11 1DB Organization: Celgene Europe LTD Schedule: Full-time Shift: Day Job Employee Status: Regular Job Type: Standard Job Level: Individual Contributor Travel: No 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. We are currently looking for a Senior Drug Safety specialist for a 6 to 12 months period based in Budapest or in the UK. This person will :   1. Contribute to regulatory credibility through delivery of outstanding quality and compliance standards and process excellence in all Affiliate Drug Safety and Risk Management (RM) responsibilities. 2. Contribute as subject matter expert for Affiliate Drug Safety and RM related issues when applicable. 3. Contribute to the GDSRM Ambassadorial role within the Affiliate as a drug safety member. 4. Contribute to effective working partnerships in collaboration with key Affiliate Stakeholders, GDSRM, GDSRM EMEA/APAC and EU QPPV in support of Celgene’s Pharmacovigilance (Drug Safety and Risk Management) System.  5. Contribute 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.   List of Key Accountabilities: Case Management and Processing • Triaging of ICSRs in order to sustain regulatory expedited reporting compliance. • ICSR Management: • Clinical ICSR management • Submission of ICSRs from Celgene Sponsored Studies • IIT case receipt pre-triage & follow-up, distribution & submission (where applicable) • Post Marketing ICSR Management • Post-marketing case receipt, pre-triage, follow-up, distribution & submission • Translations for each activity, if applicable • Ensure submission of special situations in accordance with regulatory commitments • Reconciliations from multiple sources external and internal    Risk Minimization • Support the DSRM Manager in the local implementation and maintenance of local RMin Programmes (as per the product Risk Management Plan). • Support the DSRM Manager in 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. implementation and maintenance of applicable Risk Minimisation Programmes • Translations, if applicable Management and oversight of locally led data collection activities: • Support DSRM Manager 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) • Other projects such as PASS and PAES where applicable • Registries • Pre-approval access (e.g. Compassionate Use, Named Patient Programs) • Interventional & non-interventional IIT protocols, CRFs, ICFs and contracts review • IITs Sponsors/CROs training • Support DSRM Manager, to Provide PV input/safety reporting training to Investigator Meetings including IITs and Celgene Sponsored (if applicable) • Support the reconciliation of DSURs/ASRs (periodic aggregate reports )  PV Compliance and Quality: • Support DSRM Manager in oversight of Affiliate and Partner adherence to Compliance and Quality Standards as defined by GDSRM. • Support the Implementation and comply with relevant GDSRM policies and procedures. • Compliance with regulatory PV requirements and with Celgene’s internal requirements. • Support continuous Inspection and Audit readiness and support successful and timely responses to CAPAs. • Issue management: timely escalation of potential compliance issues and support the delivery of appropriate CAPAs in collaboration with relevant GDSRM /GDSRM EMEA/APAC Functions and EU QPPV. • Maintain awareness of local content contained within the Global Pharmacovigilance System Master File.Support the DSRM Manager in ensuring Third Party Vendors conducting activities of the Pharmacovigilance System under go appropriate review and approval. Regulatory Authority Interactions: • Escalation to GDSRM of enquiries from regulatory agencies and Healthcare Professionals on safety and Risk Minimisation questions for marketed products • Support DSRM Manager to provide Local Drug Safety input into DHPC Letters (where applicable) • Support DSRM Manager to provide Local Drug Safety input to Prescribing Information maintenance and update • Support DSRM Manager in approval/notification process for Additional Educational Materials per the product Risk Management Plan (where applicable) Routine Pharmacovigilance Activities: • Report any potential safety issue in a timely, open and appropriate manner to the whom it may concern (i.e. Drug Safety Manager/Drug Safety Ass Dir, Medical Director, etc.) • Collaborate in providing Adverse Event and Risk Minimisation Programme Training to local staff/third parties • Participate in Product Quality Complaint interactions or process PQCs (where applicable) • Participate in Medical information interactions or process safety related inquiries • Contribute to the local literature review (where applicable) • Contribute to local legislation review and local gap analysis (where applicable) • AE Reconciliation with stakeholders • Collaborate in local SOPs & WPs development & maintenance • Local Drug Safety email box daily monitoring and management • Ensure Business continuity • Act as back-up to DSRM Manager if required • Maintain awareness of local Pharmacovigilance regulations   Continuous Process Improvement: • Contribute to the GDSRM deployment and conduct of local Quality and Compliance initiatives • Contribute in the Delivery of GDSRM EMEA/APAC Goals as defined in performance documents • Collaborate in the maintenance of continuous efficiency gains through identification of opportunities for process innovation and operational excellence • Keep metrics based approach to productivity and performance management in relation to defined Key Performance Indicators presented in GDSRM Safety Operations outputs and affiliate goals. Added Value: • Reinforce the GDSRM Mission, Vision and Value & Support EU QPPV Oversight of Celgene’s Pharmacovigilance System • Support safety data and Risk Minimisation requests from Affiliate stakeholders through appropriate GDSRM escalation process • Provide Pharmacovigilance expertise support to Affiliate Functions as required • Contribute to communication of GDSRM assessment of changes in Benefit: Risk evaluation for marketed products to Affiliate stakeholders, as required. • Contribute to GDSRM/ GDSRM EMEA APAC Led initiatives & projects as required   Medical Component: • Support GDSRM ability to create & maintain a single, unified product level perspective on products' safety profiles from development to marketing   Qualifications Scientific/Pharmacy degree or equivalent Pharmacovigilance experience or equivalent Excellent knowledge of applicable national Pharmacovigilance legislation Broad appreciation of global regulatory requirements for Pharmacovigilance Proficiency in technical safety systems including IRT, OST and ARISg Computer and database skills Good interpersonal skills Good written and verbal communication skills 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 Fluent English and Hungarian is mandatory

Locations

Hillingdon England UK

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