LAMBDA Therapeutics Research Limited hiring details 2021
Pharmacovigilance Freshers & Experience Jobs openings in London2021
Position – Sr. Officer & Officer,
Location – London
Job code: UKPVHLHR01
Employment Type: Permanent
Location: Harrow, London
Experience: 0 to 3 years
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
- 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.
- Case Processing
- 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 (eg. SOPS, Wls, 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
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