Manager Pharmacovigilance - Safety Review
We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world.
We estimate that Teva provides medicines to 200 million patients around the world every day.1
We develop, produce and market affordable generic medicines, as well as innovative and specialty pharmaceuticals and over-the-counter consumer healthcare products, along with supplying active pharmaceutical ingredients to nearly 1,000 customers in over 100 countries.1
We work tirelessly to transform science, research and patient insights into effective treatments for disorders of the central nervous system, pain and respiratory conditions
We would like to invite applications for the role of Manager Pharmacovigilance - Safety Review
As Manager you will lead the safety review team activities and act as line manager for PhV Officer - Safety Review team
In addition you will liaise with local/regional/global colleagues on subject matter related to UK reference safety information/labelling documents & Risk Management/ARMMs.
The successful candidate will actively represent UK LSO via participation in relevant global/regional/local work streams as applicable and as agreed with UK LSO. You will be responsible for the maintenance, update and review of local controlled documents relating to Safety Review team responsibilities to ensure compliance with global/EU standards and to manage and co-ordinate process optimisation for the UK PhV Safety Review team as necessary
To be performed in accordance with international regulatory requirements local and global Standard Operating Procedures and Working Instructions.
- Review/perform comparisons of Company Core Safety Information (CCSI) and National UK and relevant EU SmPCs, including liaison with UK Medical Affairs and Regulatory Affairs, as necessary
- Identify and confirm potential safety variations to the UK National SmPCs required, following discussion with relevant personnel as necessary e.g. UK Medical Affairs, UK Regulatory Affairs and the Global PSUR Writing Centre
- Ensure all notifications received from the CCSI Distribution System (DS) are dealt appropriately and within timelines
- Manage and perform the creation of safety variation changes in the Teva Change Control system for National UK and relevant EU licensed marketed products
- Ensure all notifications received from the RMP trackwise system are dealt appropriately and within timelines
- Alert all relevant UK personnel to specific RMP requirements as necessary e.g. Medical Affairs, Regulatory Affairs, Marketing, Launch team
- Review and advise on RMP materials that are Conditions of the Marketing Authorisation prior to implementation, liaising with UK Marketing and Medical Affairs, as necessary
- Interact with the BGMA/MHRA as necessary with respect to RMPs
- Maintenance of the Risk Management Plan Tracking System
- Manage and ensure performance of monthly checks of EMA website in respect to products that are subject to EU additional monitoring
- Ensure Teva UK change control (EPD Trackwise) is dealt appropriately and within timelines
- Prepare and deliver pharmacovigilance training on product/therapeutic areas to relevant personnel
- Prepare PSUR planning for UK licences according to corporate/local processes and procedures
- Line management and appraisal of PhV Officer in Safety Review team to include regular 1:2:1s, training and development, "My Teva Journey", objectives setting and regular review in line with PhV Leadership strategy
- Providing additional support for other Pharmacovigilance activities as necessary. Perform analysis of ad hoc safety issues, preparing and reviewing actions and responses. Liaise with relevant departments and the PhV teams, as needed
- Provide support to UK LSO for other PhV activities as necessary.
Qualifications, Experience & skills
- Degree Qualified in Life Science Subject or equivalent
- Significant experience in Pharmacovigilance
- Safety review
- Project Management
- Safety databases,
- Proficient in Microsoft Office
- Health Safety
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