9226 - Pharmacovigilance Associate I

Orion Group Life Sciences are looking for a Pharmacovigilance Associate for our Pharmaceutical client based in Harlow. 4 month project position. This is hybrid role, 2 days onsite and 3 days remote working.,

• To manage the receipt and triage of Individual Case Safety Reports (ICSRs) and Serious Adverse Events (SAEs) associated with our client in UK and Ireland pre and post marketed products in accordance with local/EU legal requirements.


• To support with the submission of our client in UK and Ireland ICSRs to the EU Hub.


• To enter ICSRs and SAEs into V-Safe as required.


• Prepare follow-up letters/emails.


• Support case management team with any other activities as required.


Responsibilities

• Case Management:

+ Receive and triage spontaneous ICSRs and SAEs received by our client for authorised, marketed and development products in the UK/IE.
+ Request and process follow-up information for ICSRs and SAEs, as necessary.

• Clinical trials:

+ Support with collection, filing and maintaining the documentation for UK/IE clinical trials and keeping local PV records updated with all relevant information e.g. safety plans, protocols, investigator brochures, as necessary.
+ Handling any trial related SAEs/SUSARs in line with applicable global and local procedures.

• Other tasks:

+ Provide support to LSO, Senior Manager, Deputy LSO UK and Ireland and/or Senior PV Professional UK and IE Case Management team with other tasks as required.


• Entry grade understanding of Pharmacovigilance.


• Good communication skills in both verbal and written English.


• Good organisation skills.


• Strong focus on internal/external customers.


• Good attention to detail.


• Team player.


• Proficient in using Microsoft Office.
  
  As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.