Safety/ Pharmacovigilance4

2 weeks ago


Cambridge, Massachusetts, United States GlaxoSmithKline Full time
Site Name: USA - Massachusetts - Cambridge, UK - London - New Oxford Street
Posted Date: Jun

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.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

Scientific/Medical Knowledge PV Expertise
  • Assists more senior SERM colleagues with safety monitoring and evaluation of assigned GSK products.
  • Under guidance helps LOCs respond to local regulatory requirements.
  • May support senior colleagues in process improvement initiatives within the global safety.


Cross-functional Matrix team leadership
  • Understanding of a matrix team and matrix team requirements
  • Capable of assisting senior colleagues in preparation for and presentations in matrix team meetings.
  • Knowledge of purpose and remit of Safety Review Teams


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Undergraduate medical or other health science discipline.
  • Experience in pharmacovigilance.
  • 2+ Years of experience in product safety surveillance and risk management for drugs in development


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Entry level knowledge of and general familiarity with pharmacovigilance and safety surveillance.
  • 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).
  • Basic self-awareness of impact on others in matrix teams; respectful and being receptive to feedback on self.
  • Basic writing and verbal communication skills - can communicate ideas in business forums such as local team meetings and across global teams as required.
  • Technical competence in Word/Excel/Powerpoint/Email apps.
  • Keeps manager/supervisor informed of progress and activities.


#LI-GSK

Please visit GSK US Benefits Summary t o learn more about the comprehensive benefits program GSK offers US employees.

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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