Drug Safety and Risk Management Specialist - CELGJP00008062


Premium Job From Experis IT

Recruiter

Experis IT

Listed on

17th June 2019

Location

Hayes

Salary/Rate

£20 - £25

Type

Contract

This job has now expired please search on the home page to find live IT Jobs.

Purpose

* To assist with delivery of ongoing activities and enhancing the Risk Management Plan for the company's products.

* To execute and support all local Risk Management (RM) related activities as directed by the UK and Ireland Head of Drug Safety and Risk Management.

* Ensure compliance with local and international regulations internal standards

* To contribute effectively as part of the Global Drug Safety and Risk Management network

* To 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 Drug Safety and Risk Management Manager

* To oversee and execute timely local case-processing activities, including ensuring robust investigation and follow-up of local safety reports for both marketed products and those under development.

* To oversee and execute timely and accurate reporting to the National Competent Authorities.

Role and Responsibilities & Risk Management:

* Tracking and (re) registration of all pharmacies administering the Pregnancy Prevention Plan (PPP) as part of the RMP associated products, communicating efficiently and effectively with Local Service Providers to ensure compliance.

* Comply to the conditions of the Marketing Authorisation of Products through preparation, planning and the implementation of PPP in accordance with local and international legislation and the agreed timelines.

* Set-up and implement measures to assess the compliance rate and effectiveness of the PPP.

* Consolidation and review of pharmacy audit data including Prescription Authorisation Forms (PAFs)/Audit Forms/Order Forms to be presented within a report for submission to the MHRA and HPRA.

* Applying measures to ensure the validity of audit data.

* Preparation and review of RM processes and documentation including SOPs/WPs and PPP periodic reports.

* Effectively liaising with the regulatory and compliance department and MHRA and HPRA, as directed by the UK and Ireland Head of Drug Safety and Risk Management, to ensure regulatory compliance.

* Effectively liaising with the Patient Access Scheme administrators to address PPP deviations.

* Preparation, review and distribution of PPP materials in accordance with GDSRM-EMEA/APAC.

SAE/AE Case Processing:

* To ensure the accurate, timely and complete receipt, evaluation and follow- up of domestic adverse event reports.

* To maintain the local archive of safety reports

* To maintain current awareness of local and global safety regulations

* To ensure compliance with local expedited and periodic regulatory reporting requirements for marketed products and those under development, utilizing ARISg and E2B.

* To contribute to the development and maintenance of corporate policies, standard operating procedures and associated documents on safety data handling

* Preparation and review of Drug Safety processes and documentation including SOPs/WPs and work aids.

* Ensuring the reconciliation activities are performed in a timely manner as per local processes.

Internal affiliate development

* To assist with training of the affiliate organisation and associated third parties on safety data reporting requirements and Risk Management Plans including the PPP.

* To capture, follow-up and ensure the appropriate persons within are notified of locally reported Product Quality Complaints.

* Enhancing the Risk Management Plan and the PPP to add value to the affiliate organization

Skills/Knowledge Required:

* Life science/Pharmacy degree or Registered Nurse

* Attention to detail

* Ability to follow standard operating procedures

* Be able to work independently and as part of a team

* Excellent written and verbal communication skills

* Previous relevant experience within a Pharmaceutical company or CRO

Leadership Competencies (Behaviours)

* Foster Teamwork-Individual Contributor Behaviors

* Demonstrate Adaptability- Individual Contributor Behaviors

* Promote Open Communication- Individual Contributor Behaviors

* Drive Execution -Individual Contributor Behaviors

If you are relevant or interested don't delay, contact me on 0161 924 1400 or email me at Jakub

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