Lambda Therepeutic Research Released Job Openings On 13-09-2021.
Vacancy Details:
Lambda Therepeutic Research Recruiting Life science graduate or health Care Professional Candidates with 00-03 Years of Experience for Officer/ Sr. Officer – Pharmacovigilance Position.Complete Details for the Officer/ Sr. Officer – Pharmacovigilance as follows.
Important Details :
- Location :Harrow, London
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 12/09/2021
- Mode of application :Online
- How To Apply: Share Your Resume career@lambda-cro.com
Job Description/Skills Required
Job Purpose
- To ensure the provision of appropriate pharmacovigilance advice to clients and colleagues, The pharmacovigilance activities within Lambda are carried out in accordance with Company’s controlled documents and relevant regulations and guidelines
- To ensure availability of regulatory awareness for tracking on going changes and for implementation of relevant regulations. To assist in the development of appropriate SOP’s for the organization and its clients.
Key Responsibilities
Medical Inquiry Handling
- Checking medical Inquiry mailbox, fax machine. phone and postage for ICSRs
- Tracking and Handling of medical inquiry in accordance with defined SOP’s
- Logging and updating of inquiry in PriTR database
- Preparation and communication of inquiry response in Liaise with designated medical reviewer
- Assist designated medical reviewer for follow up of all medical inquiry
- SDEA preparation
Submission
- Submission of ICSRs to Regulatory authority via
- Electronic and/or paper format
- Submission/Locking of cases.
- Receipt of regulatory cases from Eudravigilance
- Registration of client’s product on XEVMPD.
Secondary Responsibilities
- Case Processing
- Perform duplicate search.
- Case receipt and tracking9
- 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
Required Skills and Qualifications
- Education: Life science graduate or health Care Professional
- Basic Understanding of PV regulations with experience of safety database data entry
- Share Your Resume career@lambda-cro.com Kindly mention job code in subject line while sending your CV.
