Pharmacovigilance and Medical Information officer

UK-Kingston
Job ID
2017-1116
# of Openings
1
Category
Pharmacovigilance
Position Type
Permanent Full-Time

Overview

The UK Bausch + Lomb team is currently recruiting for a Pharmacovigilance/ Medical Information officer to join our Kingston office.  Reporting into the Regulatory Affairs Manager and based in the office, you will be part of the Global Pharmacovigilance Team responsible for coordinating the day-to-day management of the pharmacovigilance and medical information local system in the UK and Ireland (Vision Care, Pharma, Surgical and GPSS franchises) and ensuring local compliance with applicable Regulations and Corporate policies (local and global).  You will also be required to act as the National Responsible Person in terms of the EU Directive 2010/84/EC and local legislation.    You will act as primary contact for medical information enquiries. In addition you will facilitate Pharmacovigilance training at a local and regional level (as applicable). 

Responsibilities

  • Ensure all local affiliate responsibilities are fulfilled as documented globally and in the PSMF
  • Responsible for forwarding Adverse Events regarding surgical and vision care products (medical devices) to the Global Product Safety Surveillance group as necessary ensuring all cases are processed in a timely manner.
  • Prepare and manage country SOPs and written procedures according to local legislation and in line with Pharmacovigilance global SOPs
  • Ensure that local pharmacovigilance system is managed with country SOPs
  • Manage reconciliation of Adverse Events/Adverse Drug, if applicable
  • Responsible for local Pharmacovigilance (PV) acting as contact person for local health authorities and for the EU QPPV, as required
  • Support compilation of aggregate reports by providing requested data
  • Participate in global PV training activities
  • Ensure appropriate archiving of relevant documentation and correspondence
  • Support Direct Healthcare Professional Communication and other risk minimisation measures, if applicable
  • Facilitate local literature search; documentation of local literature searches
  • Communicate updates to changes in local Responsible Persons ensuring senior managers are informed
  • Keep local PV SOP updated on a regular basis
  • Act as local contact point for audit and inspections and related processes, including the preparation and maintenance of Inspection Binder
  • Support review of local agreements and compliance
  • Follow-up on any customer complaints as requiredPlanning for PV business continuity
  • Management of UK and Ireland PV contracts
  • Support global pharmacovigilance activities
  • Assist with any local risk minimisation measures/mitigation activities including developing educational materials as part of the Risk Management Plan
  • Responsible for the co-ordination of Medical Affairs activities 
  • Actively engage, support and guide all participating marketing, ensuring global alignment
  • Co-ordinates with and strategically utilizes Medical Information resources to understand evidence/confidence gaps and creates robust strategies/plans to address them
  • Reconciliation of complaints and medical information queries

Qualifications

  • Registered pharmacist desirable
  • Proven ability to work cross-functionally with a broad set of stakeholders from all functions of Global/local Medical Affairs and Commercial.
  • Broad regulatory affairs experience covering PV and medical information                  
  • General knowledge of the Medical Device Directive and ISO 13485
  • Experience in dealing with local regulatory agencies
  • Good understanding of business processes
  • Excellent communication skills – written and verbal
  • Ability to manage complex tasks in a matrix environment
  • Flexible, able to adapt and manage priorities in a fast changing environment.
  • Strong time management skills. 
  • Strong interpersonal and relationship building skills
  • High attention to detail and accuracy
  • Good planning and organisational skills
  • Good computer skills, including Excel, Word and PowerPoint

 

Desirable:

 

  • Knowledge of domestic and international post-marketing regulations preferred
  • Knowledge of applicable law regulations if not under CE mark advantageous
  • Knowledge of Global Medical Affairs (strongly preferred)

Company Overview

In this role for Bausch + Lomb you will benefit from a good package that will include:

 

  • Medical insurance
  • Pension Matched by us up to 10% (conditions apply)
  • Life assurance
  • Bonus
  • 25 days holiday with the ability to buy 5 more
  • Fresh fruit, hot and cold drinks provided
  • Free product scheme for you and a family member (includes contact lenses and eye supplements)
  • Childcare vouchers
  • Dental and Travel Insurance (voluntary benefit)

 

 

Bausch + Lomb, established in 1853, has been at the forefront of many of the visionary innovations in eye health from optical lenses to contact lenses, from eye drugs to surgery. As a successfully performing healthcare company we relentlessly pursue our mission to help patients across the world to see better, in order to live better.

With a performance culture based on “people, attitude and results”, we have passion for winning and entrepreneurial spirit that will suit any individual with a “get up and go” attitude, strong work ethic and appetite to make real, tangible impact in a constantly evolving environment.

The UK organisation employs today around 150 staff, fostering a “small company” mindset with the comfort of a large financial backer from the wider Valeant group.  We take pride in a team that is wholly dedicated to working in strong collaboration with each other and sharing knowledge and skills readily in order to further the unified company success.

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