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 : Assistant Manager - Pharmacovigilance
Job Purpose and Key Responsibilities
Business Rationale : To support the Lead Named Safety Contact (NSC) in the collection of Human Safety Information (HSI) / Adverse Events (AEs) and timely reporting of HSI / AEs to the Central Safety Department (CSD) and local regulators and related activities This includes ensuring compliance with all local regulations and GSK global Pharmacovigilance requirements, as applicable.
Responsibilities :
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 PV LSOP, for all relevant Pharma / Vaccines cases.
• Conduct PV Management Monitoring of relevant PV related activities scheduled in the beginning of the year and ensure the CAPAs, if any, arising from the Management Monitoring are followed up and closed.
• Prepare, the 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 the DSUR package and forward to the HA or to the LOC RA team for onward submission to the HA via the ePortal SUGAM, as applicable.
• Prepare and finalize the ICSR submission to the Local Health Authorities (viz., Local FDA) within the required 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, etc.
• Provide PV support to the concerned Medical team where required for local Risk Management Plan (RMP) in coordination with the Lead NSC.
• Participate in the review Safety Monitoring Plan (SMP) for relevant studies.
• 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 all local clinical study proposals/protocols to ensure adequate safety requirements are met.
• Conduct HSI / AE trainings.
• Work with the NSC / Back-up NSC for other PV related activities, as required, for activities other than the above.
Accountability :
To support the Lead Named Safety Contact in the collection of HSI / AEs and timely reporting of HSI / AEs to the Central Safety Department (CSD) and local regulators and related activities This includes ensuring compliance with all local regulations and GSK global Pharmacovigilance requirements, as applicable.
Complexity :
• Evolving India Pharmacovigilance regulations
• Enhanced Pharmacovigilance compliance standards within GSK.
Candidate Profile
Pharmacy or Science graduate
3 to 8 years of end-to-end Pharmacovigilance operations in a pharmaceutical organization with or without CRO experience. Exposure to all phases of Clinical Trials on Pharmacovigilance, will be an added advantage.
Additional Information
Experience : 3 to 8 years
Qualification : Pharmacy or Science graduate
Location : Worli Mumbai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Pharmacovigilance
End Date : 28th February, 2023
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