To ensure the provision of appropriate pharmacovigilance advice to clients and colleagues.
To ensure pharmacovigilance activities within Lambda are carried out in accordance with Company’s controlled documents (SOPs, WIs, and Guide), relevant regulations and guidelines.
To provide support to other members of the pharmacovigilance team as required.
To support and assist less experienced team members to enable them to fulfil their roles.
Regulatory Intelligence: Awareness of changes to and implementation of relevant
Assist in the development of appropriate Standard Operating Procedures for Lambda’s Pharmacovigilance Department and clients.
Communication with clients and/or regulatory agencies if required
Any other tasks as requested as by line manager to meet business requirements.
Medical Inquiry Handling
Ensure that Medical Inquiry mail box, fax machine, phone and postage are checked daily for ICSRs.
Tracking and Handling of medical inquiry in accordance with company’s controlled documents (e.g. SOPs, WIs, Guide)
Logging of query and updation of medical inquiry log
Preparation and communication of inquiry response in liaise with designated medical reviewer.
Assist designated medical reviewer for follow up of all medical inquiry
Reconciliation of medical inquiries received from clients and their affiliates, business partners.
Reconcile and acknowledge adverse events/product complaints emails in accordance with safety data exchange as per SDEA and PMP.
Regulatory website monitoring
Perform duplicate search.
Case receipt and tracking
Case processing including data entry, Drug coding, MedDRA coding, Listedness, assessment for expediting, narrative writing of ICSR in accordance with Company’s controlled documents (e.g. SOPs, WIs, Guide) relevant regulations and guidelines.
Preparation, revision, review of SOPs, Wls, templates, guide and guidance training documents
Communication of urgent safety issues to Line manager
Ensure communication with all relevant people is of a high professional standard, and that records of both internal and external communication are maintained
Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company’s global Pharmacovigilance requirements
Deliver training to new joinee and team as per requirement
Work with the Aggregate report/ ICSR team/Medical review team leader to escalate issues or tasks outside the normal scope of work.
Required Skills and Qualifications
Life Science graduate or Health Care Professional
Basic Understanding of PV Regulations
Experience of safety database data entry
Demonstrated competency in case handling and narrative writing
Attention to detail and quality focus
Good written and verbal communication skills
Proactive approach to work
Good planning and organizational skills
Job Types: Full-time, Contract
Salary: £18,000.00 /year