Assistant Manager

Site Name: India - Maharashtra - Worli Mumbai

Posted Date: Aug

Job Purpose

To support the Lead Named Safety Contact (NSC) in the collection of Human Safety Information (HSI)/ Adverse Events (AEs) and forward to Global service provider for onward processing and handling of submission of SAEs (Sponsor) related to clinical trials for which LOC India is responsible. Timely reporting of HSI / AEs to the local regulators as applicable. This includes ensuring compliance with all local regulations and GSK global Pharmacovigilance requirements, as applicable.

Operational:

• Responsible for Pharma and Vaccines Pharmacovigilance.
• Review of Safety Mailboxes (PV Mailbox and IN Safety) on a daily basis for action to be taken.
• Review of IN Safety Mailbox on a daily basis for action to be taken with regard to regulatory reporting, as applicable.
• Review of HSI / AEs received in the PV mailbox, redact the cases where consent for use of PII / SPD of consumer has not been received / no response received and forwarding to Global Service Provider for onward action.
• Respond to queries / emails from Global Safety Provider, coordinate with them, and other PV related activities, as required on a case-by-case basis.
• Provide continuous support, as required, to the Global Service Provider for PV related activities handled by them.
• Conduct follow up, within timelines per Country Operating Manual (COM), for all relevant Pharma / Vaccines cases.
• Conduct PV Management Monitoring of relevant PV related activities scheduled for the year and ensure the CAPAs, if any, arising from the Management Monitoring, are followed up and closed.
• Prepare India-specific PSUR (Periodic Safety Update Report) of relevant Pharma and Vaccines products and forward to the relevant regulatory department for submission to the HA.
• Submit the Clinical Trial SAE Sponsor causality to Health Authority via SUGAM system and related activities in SUGAM.
• Forward the submission proof to the Global Service Provider for updating the submission date in the safety database.
• Forward the due analysis for Clinical trial SAEs to Ethics Committee and Head of Institute.
• Prepare and finalize the ICSR submission to the Local Health Authorities (viz., Local FDA) within the agreed timelines.
• Maintenance of relevant local trackers for PV related activities.
• Notify the MSV (Medical Information and Safety Services Vendor Management) Team regarding any new Market Research / Patient Support Program / Patient Access programs / Interactive Digital Media, New Studies, New Product launched, etc.
• Provide PV support to the concerned medical team where required for local Risk Management Plan (RMP) in coordination with the NSC.
• To co-ordinate for the Inspections and Audits related documents and work on the CAPAs for the findings received during the inspections and Audits.
• Respond to PV related queries received from the HA, e.g., PSUR related, CT SAE, ICSR submission related, etc., as applicable.
• Participate in the review of relevant clinical study proposals/protocols/ Safety Monitoring Plan (SMP) and other relevant documents to ensure adequate safety requirements are met, from PV perspective.
• Conduct HSI / AE training as required.
• Participate in the conduct of PV related activities with regard to joint ventures, takeovers, mergers etc.
• Work with the NSC / Back-up NSC for other PV related activities, as required, for activities other than the above.

Qualifications/Skills

Basic Qualifications:

• Bachelor's degree in Science, Pharmacy, Life Sciences, or equivalent a related field.
• Minimum 3 years of experience in pharmacovigilance operations.
• Strong understanding of pharmacovigilance regulations and methodologies.
• Proficiency in safety databases and IT systems, including Excel.
• Excellent attention to detail and organizational skills.
• Effective communication skills, both written and verbal.
• Time management
• Prioritization of work

Preferred Qualifications:

• Master's degree in Health Sciences or related field.
• Experience in clinical trial safety reporting from Sponsor perspective and regulatory submissions.
• Familiarity with aggregate reports (e.g., PSURs) and risk management plans.
• Ability to work collaboratively in a matrixed environment.
• Experience with audits and inspections in a pharmacovigilance setting.
• industry experience in PV preferred.

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 and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – 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.

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