Pvasc Specialist I

4-7 years

Not Disclosed

Bangalore Bengaluru

10 Feb. 21, 2024

Job Description

Job Type: Full Time Education: Any Graduate Skills: Communication Skills, Interpersonal Skill, Technical Skill

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 Sr. PVASC Specialist III is to work with a reasonable level of independence to achieve one or more of the Key Responsibilities mentioned below.

Key Responsibilities :

Expert 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.
Expert 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 independently on this task, identifying and escalating findings and issues as required.
Proficient 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.
Expert in collection, evaluation, analysis, and documentation of information received from local operating company safety departments.
Expert in running standard listings from databases as required.
Expert to administer document storage and archiving including team site per the approved processes.
Represents during both external regulatory inspection and GSK audits of licensing partners 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 minimum supervision from senior staff.
Contributions/leads projects relating to improvements in processes and systems e.g., EDMS with supervisions from senior staff.
Performs other duties as assigned with supervisions from senior staff.

Education Requirements:

Bachelor/Master degree (scientific or medically related field is preferred) with a minimum of 5-7 years working experience in the pharmaceutical industry in clinical development, pharmacovigilance and information management or equivalent work experience.

Why Us?

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 organization 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.

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

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