Serm Scientist

Site Name:
Bengaluru Luxor North Tower

Posted Date:
Jun 2 2023

Job Purpose
Provides entry level scientific knowledge in the safety evaluation and risk management.

Under the guidance of Senior team members, ensures that adverse event and other safety information is efficiently evaluated to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives.

Key Responsibilities

**Minimum years of Experience and other requirements: - **3-6 years of experience in PV domain especially aggregate report writing and signal management

• Fluent English and communication skills.
• Good working knowledge of medical and drug terminology.
• Good working knowledge of relevant pharmacovigilance regulations and methodologies applicable to SERM activities.

1.

Scientific/Medical Knowledge PV Expertise:

• Entry level knowledge of and general familiarity with pharmacovigilance and safety surveillance.
• Assists more senior Safety Evaluation and Risk Management (SERM) colleagues with safety monitoring and evaluation of assigned GSK products.
• May review ICSRs and literature articles for Safety topics of interest and detection of safety signals.
• Helps draft Aggregate Report safety sections and support addressing response to queries (RTQs).
• Under guidance helps local operating countries (LOCs) respond to local regulatory requirements.
• May support senior colleagues in process improvement initiatives within the global safety.

2.Cross-functional Matrix team leadership:

• Understanding of a matrix team and matrix team requirements.
• Basic selfawareness of impact on others in matrix teams; respectful and being receptive to feedback on self.
• Capable of assisting senior colleagues in preparation for and presentations in matrix team meetings.
• Knowledge of purpose and remit of Safety Review Teams.

3.

Communications (verbal, written) and Influencing (internal PV Governance and External LTs):

• Basic writing and verbal communication skills can communicate ideas in business forums such as local team meetings and across global teams as required.
• Keeps manager/supervisor informed of progress and activities.

Education Requirements (minimum expected)
Undergraduate medical or other health science discipline. Graduate degree preferred. Exposure to pharmacovigilance or drug development.

Job Related Experience Requirements
This role is an entry level role to Pharmacovigilance. It is preferred to have some exposure to pharmacovigilance or drug development. Alternatively, health care experience.

Scope of Accountability
Entry-level safety data review, data compilations and signal detection.
Provides scientific knowledge in the safety evaluation and risk management.

**Additional Requirements for The Job:
- **
Additional Key Responsibilities

• Ensures that adverse events and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements.
• Provides, with some support, safety input on crossfunctional teams.
• Responsible for maintenance of labelling for assigned GSK products.
• May assist in review of Safety Data Exchange Agreements and escalates any deficiencies to the SERM Team Leader to ensure quality and integrity of agreement.
• Supports the Local Operating Companies by preparing license renewal documentation (e.g. Addendum Reports, Line listings, Clinical Overviews) as required for each market.
• Authors or assists in the production of global Risk Management Plans/ regional Risk Management Plans for designated products, in consultation with senior colleagues.
• May contribute to Regulatory Benefit-Risk Assessments requiring safety team input.
• Conducts review/ assist in review of list of studies and identifies TSS/ PASS status in consultation with senior colleagues. Ensures prompt notification to SERM Team Leader of any studies that are identified as potential PASS.
• Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
• Raises concerns/ issues to the line manager in a timely, open and appropriate manner; ensures quality and integrity of issue/ event being escalated.

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 positively impact the health of 2.5 billion people by the end of 2030.

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 GS

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