Haleon Hiring Consumer Safety Writing Scientist
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.
As GSK Focuses On Our Values And Expectations And a Culture Of Innovation, Performance, And Trust, The Successful Candidate Will Demonstrate The Following Capabilities
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork.
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