Location
Bangalore | India
Job description
Site Name: Bengaluru Luxor North Tower
Posted Date: Jan 25 2024
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
Why GSK Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: - Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness
- This is a job description to aide in the job posting, but does not include all job evaluation details.
Why Us 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 organization 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 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.
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