GlaxoSmithKline Pharmaceuticals Ltd is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders.
Post : CS Science Sr Scientist
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.
• 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
• Doctor of Medicine (MD)
• Strong collaboration, planning, execution, and communication skills
• Ability to influence across a highly-matrixed organization
Qualification : Pharm.D
Location : Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical and Clinical
End Date : 25th November, 2021
See All Other Jobs in our Database