Job Ref: 213328767

Date: 2021-03-10 08:52:22

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Orion Group are recruiting for an International Pharmacovigilance (IPV) Case Management Specialist on behalf of our Multinational Pharmaceutical Client on an initial 12 month contract based in the Buckinghamshire Area

Principal Responsibilities:

Ensuring Individual Case Safety Report (ICSR) case processing and related activities are carried out to enable compliance with applicable regulatory requirements, company procedures, at a local/regional level or global level, and in compliance with provisions of PV agreements with business partners.
The scope of support is primarily focused on countries. The role holder may be expected to support and ensure case management and related activities for other countries within the EMEA Region (centralized case management) are carried out in a timely manner.
Receipt, assessment and processing of incoming safety information from multiple sources, both internal and external to the Company.
Enter relevant/required safety data into the Global Inbound Receipt System (GIRS) from spontaneous, clinical trials and other solicited sources.
Provision of safety information/acknowledgements to marketing partners/other third-party partners/Global Medical Safety within the internal and contractual timelines.
Data entry for complex cases (seek support from senior specialist as applicable)
Performing follow-up for requesting additional information from multiple sources.
Assist in the quality review of data captured in the GIRS as applicable
Verify and ensure translation of safety information, if applicable.
Continual monitoring, assessing the reportability of ICSRs due for regulatory reporting, and submitting to respective Competent Authorities (CAs) / Business Partners (BPs), as applicable.
Enable mechanisms to support LSO oversight for case management activities as applicable. e.g. escalation non-conformance in a timely manner.
Liaise with applicable stakeholder to support case processing requirements for Medical device vigilance, materiovigilance, or cosmetovigilance (as applicable).
Collaborate with other IPV Case Management Specialists, IPV Case Management Team Leads, IPV Case Management Regional Lead, case processing SMEs in GMS/OCMS, local medical safety medical team and IPV Affairs, in addressing internal and external ICSR related queries.
Advise the IPV Case Management Team Lead in making IPV case management related decisions of a local, regional or global impact as applicable.Desired Experience:

A degree in life, health or pharmaceutical sciences is preferred.
5+ years' experience in this area Drug & Product Safety Operations
Proficiency in Medical terminology (local languages).
Familiarity with global ICSR related global, regional and local PV procedural documents as applicable.
Computer literate with expert knowledge of the Intake (GIRS) and/or expedited reporting (OST) module(s)
Ability to prioritize and work to strict timelines daily
Knowledge and understanding of key legislation applicable to pharmacovigilance within
Proven expertise and experience in pharmaceutical regulations and R&D processes is desirable#Pharmaceutical #multinational #product #IPV #Casemanagement #ICSR #PV #pharmacovigilance

For more information on this role, call Denise Cagney on +353 (0) (phone number removed) or email (url removed) for a completely confidential chat about this role

Our role in supporting diversity and inclusion
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

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