GSK D Pharma Sr Scientist Vacancy 2021 – Apply Online
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. Check out all the details on the same below:
Job Title: CS Science Sr Scientist
Location: Hyderabad, India
Req Id: 305610
Eligibility Criteria:
They 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
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 the 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 regulations 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 inquiries (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 inquiry 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.
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