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Job Title: NSC Backup

Are you energized by a highly visible safety role that ensures the accuracy of critical safety data?  If so, this Safety Pharmacovigilance Manager role could be an ideal opportunity to explore.

As a Safety Pharmacovigilance Manager, you will be responsible for ensuring local regulatory obligations for clinical safety reports are met.  This includes the appropriate collection, processing and reporting of adverse events (AEs) for GSK marketed and investigational products.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Review, extract, and accurately enter Adverse Event (AE) data from marketed product, reports received from spontaneous and solicited sources including health professionals, sales representatives, consumers and drug information in accordance with defined case handling procedures

• Review, extract, and accurately enter all serious AE information from clinical trial reports in accordance with defined case handling procedures

• Interpret case-related information including medical conditions, lab results and procedures, as well as compile complete and accurate narrative summaries

• Ensure proper coding of Adverse Event terms and other medical terms into the global AE database.

• Process and prepare reportable cases within applicable timelines including accurate determination of expectedness using the relevant core safety information

• Review and comment on protocols/Case Report Forms (CRFs) for established and new products/programs and develops appropriate data entry protocol specific guidelines

• Remain current with case handling standards, guidance documents and database technology.

• Demonstrate in-depth working knowledge of regulatory environment & ensures compliance with safety data exchange agreements

• Work with departmental teams in maintaining and upgrading the safety database

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree 

• Experience with Good Clinical Practices (GCCP), clinical safety documentation and reporting of adverse events from clinical trials

• Experience with local regulatory requirements and pharmacovigilance methodology

• Experience working with the principles of data collection, manipulation and retrieval

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Advanced Degree in Life Sciences or medical field

• Previous experience as a Health care professional (e.g. pharmacist or nurse)

• Demonstrated planning and organizational skills

Please take a copy of the Job Description, as this will not be available post closure of the advert. 
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.

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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GSK is an Equal Opportunity/Affirmative Action Employer. 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.

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