Principal Scientist, Pv Operations

4 weeks ago

Bengaluru Karnataka, India GSK Full time

**Site Name**: Bengaluru Luxor North Tower
**Posted Date**: Dec 11 2024
**Are you looking for a high-profile safety role that ensures the accuracy of critical safety data across multiple geographies? If so, this Safety Pharmacovigilance Manager role could be an ideal opportunity to explore.**:
**As a Safety Pharmacovigilance Manager, you will manage the set-up, handover, and oversight of the Pharmacovigilance (PV) Hub’s various country requirements, ensuring high PV standards and following regulatory mandated requirements across designated country clusters. You will be responsible to ensure there is close alignment with respective General Managers (GMs) to ensure governance requirements.**:
**This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following**:

- ** Responsible for day to day management of Adverse Event (AE), incident and pregnancy reports for all countries within the Hub.**:

- ** Accountable for exchange of safety data with licensing partners and maintenance of report files for local Safety Data Exchange (SDE) agreements as necessary.**:

- ** Responsible for fulfilling local regulation for reporting to local regulatory authorities within mandated timeframes for expedited reports.**:

- ** Ensure relevant training to authorized external third parties and internal stakeholders on literature review purposes, adverse event reporting, and medical information queries.**:

- ** Notify CSD of any new GSK sponsored external facing websites that include free text facility.**:

- ** Ensure a process is in place to identify and process AEs from websites including additional responsibility for medical information processes within the assigned country clusters.**:

- ** Monitor locally published medical and scientific literature to identify reports which may not have been indexed on commercial or internal literature databases and for documenting the local literature review monthly.**:

- ** Ensure there is an established process for liaison with the relevant departments dealing with product complaints and medical enquiries (in all countries).**:

- ** Regular review of local product complaint log to ensure that AE, incident or pregnancy information reported in association with a product complaint or medical enquiry is notified to the Named Safety Contact (NSC).**:

- ** Escalate issues to the relevant GSK CSD and Manufacturing Site Complaints Coordinator (in all countries).**:

- ** Day to day management of AE, incident and pregnancy reports in GSK sponsored clinical studies within specific timeframes.**:

- ** Notify the appropriate legal department and Head of the relevant CSD of any potential or actual legal action or liability with respect to human safety.**:

- ** Responsible for governance of the Pharmacovigilance/Medical Information operations within designated clusters and coordination of central requests.**:

- ** Serve as Internal GSK reference point of contact for Local Operating Companies (LOCs)/Rep Offices/Do Not Promote (DNP)/Direct to Government (DTG) and central teams.**:
**_ Why you?_**:
**Basic Qualifications**:
**We are looking for professionals with these required skills to achieve our goals**:

- ** PharmD (Pharmacists degree)**:

- ** 2 or more years of experience working in the pharmaceutical industry**:

- ** Experience in Pharmacovigilance and Medical Information regulatory requirements, systems, and processes**:

- ** Experience with medical governance across multiple geographies**:
**Preferred Qualifications**:
**If you have the following characteristics, it would be a plus**:

- ** Doctor of Medicine (MD)**:

- ** Strong collaboration, planning, execution, and communication skills**:

- ** Ability to influence across a highly-matrixed organization**:
**_ Why GSK?_**:
**_ Our values and expectations are at the heart of everything we do and form an important part of our culture._**:

- ** Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.**:

- ** Continuously looking for opportunities to learn, build skills and share learning.**:

- ** Sustaining energy and well-being**:

- ** Building strong relationships and collaboration, honest and open conversations.**:

- ** Budgeting and cost-consciousness**:
**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology

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