GSK looking for PVASC Specialist

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Post : PVASC Specialist I

Job Purpose
The key purpose of this role is to support Pharmacovigilance Operations PV Ops – PVASC (Pharmacovigilance Agreements and Safety Clauses) team. The position holder is responsible for alignment with GSK standards and regulatory timelines whilst driving the implementation of robust processes for successful PVASC operation activities. The essence of PVASC Specialist I is to work with a reasonable level of independence to achieve one or more of the Key Responsibilities mentioned below.

Key Responsibilities :
• Good knowledge in monitoring compliance by GSK and Third Parties with PVASC by carrying out routine reconciliations and compliance checks and communicating standard information to Third Parties as required with appropriate guidance.
• Good knowledge in monitoring compliance with regulatory and internal quality of global adverse event reporting. This can include performing Quality Assurance assessments of adverse event reports entered in the GSK global safety database. Role will work on this task, identifying and escalating findings and issues as required with supervision from senior staff.
• Good knowledge in maintenance of information in the pharmacovigilance database, Electronic Data Management System (EDMS), PVASC website pages and shared areas including routine maintenance and documenting information as requested.
• Good knowledge in collection, evaluation, analysis, and documentation of information received from local operating company safety departments.
• Good knowledge in running standard listings from databases as required.
• Good knowledge to administer document storage and archiving including team site per the approved processes.
• Represents during both external regulatory inspection and GSK audits of Third Parties with supervision from senior staff.
• Provides inputs, to and maintain guidance documents and SOPs.
• Can interact with colleagues in SERMs, Business Development, Operating Companies, and external companies as necessary with supervision from senior staff.

Candidate Profile
• Bachelor/master's degree (scientific or medically related field is preferred) with a minimum of 4-9 years in the pharmaceutical industry in clinical development, pharmacovigilance and information management or equivalent work experience.
• Good knowledge of data collection and interpretation.
• Good oral and written communication skills.
• Good computer skills including Word, Excel, PowerPoint, and SharePoint.
• Ability to work with tight deadlines while under pressure; demonstrates planning and organizational skills.
• Results driven with a sense of urgency that ensures timelines within personal control are met.
• Good judgement, common sense, and pragmatism.
• Functions as a team player.
• Ability to work independently.
• Able to build and maintain relationships outside of functional area.
• Proactive problem identification.
• Bridges personal, business, and cultural differences to work effectively in team settings.
• Good in stakeholder management and customer focus.

Additional Information
Experience : 4-9 years
Qualification : Bachelor/master's degree
Location : Bengaluru
Industry Type : Medical and Clinical
Req ID : 400081
End Date : 30th July 2024