Senior Drug Safety and Risk Management Specialist
Stockley Park, Uxbridge
£32.50/h PAYE only
High level responsibilities include:
Oversee and lead local pharmacovigilance related activities as directed by the Head of Drug Safety and Risk Management, UK and Ireland.
Ensure compliance with local and international regulations and our internal standards.
Contribute effectively as part of the WorldWide Patient Safety network.
Assist the Head of Drug Safety and Risk Management, UK and Ireland by accurately and thoroughly training and mentoring junior members of staff to ensure compliance within the Drug Safety and Risk Management department.
Represent the Drug Safety and Risk Management department within the affiliate as a point of reference internally for
Drug Safety and Risk Management queries, under the supervision of the Head of Drug Safety and Risk Management, UK and Ireland.
Under the supervision of the Head of Drug Safety and Risk Management, UK and Ireland assist in the development of the Drug Safety and Risk Management function.
Role and Responsibilities include (but are not limited to):
Comply to the conditions of the Marketing Authorisation of our Products through preparation, planning and the implementation of additional Risk Minimisation Measures (aRMMs) as described in the Risk Management Plan (RMP) (e.g. Pregnancy Prevention Programmes [PPP]) in accordance with local and international legislation and the agreed timelines.
Support measures to assess the key performance indicators, compliance rate and effectiveness of the implemented aRMMs. Monitor adherence to the PPP and deliver refresher training as required.
Communicate efficiently and effectively with Local Service Providers to ensure compliance to our aRMMs.
Oversee the management of the Risk Management Mailbox and support the DSRM Specialists with any queries received from HCPs.
Oversee the quality review of electronic Risk Management Programme system data output against paper Prescription Authorization Forms PAFs.
Lead the preparation and review of Risk Management processes and documentation including SOPs/WPs and associated documents.
Review RMP Annex 10 and update for UK & Ireland as required.
In collaboration with supply chain and customer care, lead the reconciliation of PAFs submission against IMiD supply. Follow-up with non-compliant pharmacies to resolve discrepancies.
Lead the preparation and update of Local Risk Minimisation Additional Educational Materials (AEMs) and associated documents for our products. Oversee distribution through to completion.
Oversee timely tracking and quality check of self-audit and order form data.
Lead the preparation and analysis of periodic reports associated with the aRMMs (e.g. audit reports, order form reports) associated with monitoring the compliance and effectiveness of the implemented aRMMs, for submission to the MHRA and HPRA.
Effectively liaise with the Regulatory and Quality and Compliance department(s) and MHRA and HPRA, as directed by the UK and Ireland Head of Drug Safety and Risk Management, to ensure regulatory compliance.
Work closely and deliver training to the Drug Safety and Risk Management Specialist on all drug safety related activities to ensure compliance with local and global SOPs and WPs.
Act as a back-up for the Drug Safety and Risk Management Specialist and the Head of Drug Safety and Risk Management, UK and Ireland for drug safety related activities.
Maintain current awareness of local and global safety regulations and review local legislation and guidance published by the MHRA and HPRA on a monthly basis and complete an impact analysis if required.
Lead and develop drug safety related projects, under the supervision of the Head of Drug Safety and Risk Management, UK and Ireland, to ensure compliance with local guidance.
Work closely with the Global Drug Safety and Risk Management and other affiliate functional groups team to fulfil any requests including, but not limited to, follow-up queries and updates to the Pharmacovigilance System Master File (PSMF).
Lead the development, update and maintenance of local SOPs, WPs and associated documents.
Lead the review and input into safety sections of abbreviated prescribing information for newly authorised medicines and for updated Summary of Product Characteristics (SmPC).
Attend and provide Drug Safety input in meetings with third-party vendors and other functional groups.
Initiate fast-track follow-up process for pregnancy reports received for drugs with known/suspected teratogenic effects.
Enter new/updated local deviations impacting affiliate PV procedures for the inclusion into the PSMF.
Review Investigator Initiated Trial protocols and Informed Consent Forms to ensure Pregnancy Prevention Programme (PPP) is in line with our PPP.
Maintain current awareness of the safety profile of marketed company products using SmPCs.
Internal affiliate development
Deliver training of the affiliate organisation and associated third parties on safety data reporting and Risk Management Plans/aRMMs requirements.
To capture, follow-up and ensure the appropriate persons are notified of locally reported Product Quality Complaints.
Timely escalation of potential compliance issues and deviations, assisting the development of non-compliance observations and associated CAPAs.
Support the Head of Drug Safety and Risk Management (UK and Ireland) during audits and inspections.
Provide advice on pharmacovigilance issues to other internal departments, or regional project teams.
To prepare/review/present pharmacovigilance documentation for internal and external customers and to represent the affiliate Drug Safety and Risk Management Department on a company level under the supervision of the UK and Ireland Head of Drug Safety and Risk Management.
To mentor and develop more junior colleagues, driving development of the drug safety and Risk Management function to add value to the affiliate organisation.
Skills and Knowledge Requirements:
Scientific/Pharmacy degree or equivalent
Pharmaceutical company or CRO experience, with at least 3 years of Pharmacovigilance experience preferred.
Good interpersonal and communication skills, both written and verbal
Commitment to follow Standard Operating Procedures
Strong attention to detail and accuracy is required
Knowledge of medical terminology and ability to summarise medical information
Ability to lead projects under the supervision of the Senior Manager or Associate Director
Ability to prioritize, plan and organize workload and ability to work under strict timelines
Good computer skills in Microsoft environment (Microsoft Excel, Power point and Word)
Demonstrated success working both independently and in collaboration with others
Adaptability and the ability to deal with a pressurized environment
Strong identification with our values
Decision-making and problem-solving skills
Leadership Success Behaviours
Inspire and motivate