Job Description

Job Purpose

The key purpose of this role is to support Pharmacovigilance Operations \xe2\x80\x93 LOC Oversight in the following activities:

Strategic oversight of region/LOC

Interaction with LOC/MD/GM/Regional clinical Ops and regulatory affairs

POC for LOC audits and inspections

Monthly regional update management

LOC escalation and regulatory update impact

COM implementation and oversight

Monthly Compliance and Quality metric oversight and escalation

The position holder is responsible for the above elements in alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PV operations activities, including vendor oversight.

Why you?

BA/BS or equivalent educational qualifications

Min 3-5 years\xe2\x80\x99 experience working in PV operations

Scientific or medically related discipline; pharmacovigilance or medical information experience preferred

Interact with PV Regional Directors, to ensure strong PV connectivity, proactively identify risks that may impact the PV system.

Interact with GPOs across Global Safety, and the LOCs to ensure alignment in the approach for local documents

Support local Named Safety Contacts to ensure PV compliance in the regions/countries.

Escalate non-compliance in the region to PV Regional Directors as appropriate

Support regional/local issue management activities, including SQIs, and support escalation needs as needed.

Support Implementation of new regulations in their region by liaising with central/regional teams and third parties.

Support internal GSK & 3rd Party Audits/Inspections.

Attend Regional PV Director area meetings, as needed

Partnering with NCS and to manage PV risks.

Active participant in Network meetings

Support queries from the LOC\xe2\x80\x99s and other key stakeholders and respond as appropriate.

Support Country Operations Manual template and LOC specific COMs with the NSCs

Contribute to training curricula for LOC staff, NSC

Generate compliance reports to support the PV Regional Directors as applicable.

Support training / drop in Q&A sessions

Perform delegated activities from the PV Regional Directors as requested

Why GSK?

GSK is a global biopharma company with a special purpose \xe2\x80\x93 to unite science, technology and talent to get ahead of disease together \xe2\x80\x93 so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns \xe2\x80\x93 as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030. \xe2\x80\x8b

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it\xe2\x80\x99s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves \xe2\x80\x93 feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.\xe2\x80\x8b

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GlaxoSmithKline