Senior Drug Safety and Risk Management - CELGJP00008061


Premium Job From Experis IT

Recruiter

Experis IT

Listed on

17th June 2019

Location

Hayes

Salary/Rate

£40 - £45

Type

Contract

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

Description:

* To lead ongoing activities, enhancing the Risk Management Plan for the company's products.

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

* Ensure compliance with local and international regulations and internal standards

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

* To assist the UK and Ireland Head of Drug Safety by accurately and thoroughly training and mentoring junior members of staff to ensure compliance within the Drug Safety and Risk Management Department in the affiliate

* 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 Authorities

* Under the supervision of the Drug Safety and Risk Management Manager, develop the Drug Safety and Risk Management function within the affiliate

Role and Responsibilities & Risk Management:

* Tracking and (re) registration of all pharmacies administering RMP associated products, communicating efficiently and effectively with Local Service Providers to ensure compliance to RMP.

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

* Set-up and implementation of measures to assess the compliance rate and effectiveness of the RMP

* 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 IMB

* Responsible for applying measures to ensure the validity of audit data

* Preparation and review of RMP documentation including SOPs/WPs and RMP reports

* Effectively liaising with the regulatory department and MHRA and IMB to ensure regulatory compliance.

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

* Preparation, review and distribution of RMP materials in accordance with EU GDSRM.

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

Pharmacovigilance

* To maintain current awareness of the safety profile of the development and/or marketed company portfolio and their most relevant competitors

* To maintain current awareness of the current product labeling on all products (IB, National, SPC, Core label, US PI)

Internal affiliate development

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

* To 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 Drug Safety and Risk Management Manager.

* To mentor and develop more junior colleagues, ensuring development of the Drug Safety and Risk Management function to add value to the affiliate organization

* Uphold and promote the company externally by demonstrating high professional standards and integrity in all external contacts

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

Skills and Knowledge Requirements:

* Life science/Pharmacy degree or Registered Nurse

* Attention to detail

* Ability to lead projects under the supervision of the Drug Safety Associate Manager

* Ability to follow standard operating procedures

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

* Strong identification with values

* Excellent written and verbal communication skills

* Minimum of 4 years 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

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