SERM Principal Scientist

Employer
GSK
Location
Rockville, Maryland
Salary
Competitive
Closing date
Dec 8, 2022

View more

Sector
Science, Pharmaceutical
Organization Type
Corporate
Jobseeker Type
Professional
Are you looking for a high-profile safety role that ensures the accuracy of critical safety data across multiple geographies? If so, this SERM (Safety Evaluation and Risk Management) Principal Scientist role could be an ideal opportunity to explore.

Job Purpose

As a SERM Principal Scientist, you will work closely with the SERM physician to actively manage and evaluate risks associated with assigned vaccine projects, and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks.

Details ( Your Responsibilities ):

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
  • Coordinate and perform initial analyses of adverse event reports and/or signal detection activities for assigned vaccine projects in clinical development and post-licensure.
  • Be the safety contact person for Clinical, Regulatory Affairs, regional and LOC (local operating company) safety managers, manufacturing teams for assigned vaccine projects.
  • Provide input to Clinical Teams with respect to safety aspects of the design and preparation of protocols, investigators brochures, investigator letters and reports, and lead the safety analyses of the assigned projects.
  • Contribute to the creation, maintenance and implementation of (D)CSI (Development, Core Safety Information) for the assigned projects.
  • Contribute to the Benefit-Risk Assessment and risk identification, assessment and mitigation activities for assigned vaccine projects.
  • Perform database searches to obtain information from the Safety Database.
  • Assist in the review of aggregated adverse event reports for signal detection, evaluation and management purposes for assigned vaccine projects.
  • Assist in drafting relevant clinical safety reports (including labeling documents, ad hoc reports and position papers) in collaboration with the safety physician.
  • Assist in the review of protocols, study reports, IDMC charters, and operational activities associated with appropriate data provision and presentation of material.
  • Contribute to the design, tracking and follow up of risk management plans for the products assigned and assure their sound implementation.
  • Summarize safety data effectively for use in regulatory or clinical trial documents (e.g., ad-hoc queries, PBRERs, PSURs and DSURs).
  • Assist in answering and follow-up of inquiries from regulatory authorities and other bodies (e.g., Ethics Committees) regarding safety-related aspects.
  • Contribute to or even lead the cross-functional Safety Review Team for assigned vaccine project(s).
  • Assist in the implementation and follow-up of safety data exchange agreements for products assigned.
  • Contribute to process improvement and documentation/discussions on procedures; provide support for training to stakeholders.


Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:
  • Bachelors degree (or international degree equivalent) or higher in a biomedical or health care-related specialty.
  • 2-3 years clinical safety experience or equivalent experience (e.g., clinical development in a pharmaceutical company, contract research organization, regulatory authority, academic research center).


Preferred Qualifications:

If you have the following characteristics, it would be a plus:
  • Basic understanding of safety evaluation methodology and awareness of pharmacovigilance regulations and methodologies.
  • Understanding of medical terminology.
  • High degree of accuracy with attention to detail.
  • Detail oriented; methodical and analytical approach.
  • Good communication skills, team spirit, flexibility.
  • Ability to manage crisis, monitor safety issues and work under pressure with a customer and solution oriented approach.
  • Able to prioritize activities effectively and to meet multiple deadlines successfully with attention to detail, setting high performance standards for quality
  • Demonstrated initiative and creativity in performing task and responsibilities. Proactively contributes ideas to improve existing operations
  • Good English writing skills.
  • Computer literate, familiar with using scientific and clinical databases.


Why GSK?

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.

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.

#LI-GSK

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.

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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

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