Life Sciences SERM Scientist Job at GSK, Apply Online
Life Sciences SERM Scientist Job at GSK, Apply Online. GlaxoSmithKline Senior SERM Scientist job opportunities. Careers at GSK. GlaxoSmithKline GSK Bengaluru vacancies for Senior SERM Scientist. Check out all of the details below –
Name of the Position – Senior SERM Scientist
Locations – Bengaluru, India
Categories – Medical and Clinical
Req ID – 342828
Job description
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
- Can you describe your experience with Good Clinical Practices and clinical safety documentation?
Answer: In my previous role, I was responsible for ensuring that clinical safety reports were in compliance with Good Clinical Practices (GCP) and all relevant regulatory requirements. This included the collection, processing, and reporting of adverse events from clinical trials. I have extensive experience with these processes and understand the importance of accuracy and attention to detail in this role.
- How do you ensure that adverse events are accurately recorded and reported within applicable timelines?
Answer: To ensure timely and accurate reporting, I review and extract all serious adverse event information from clinical trial reports and enter it into our database in accordance with defined case handling procedures. I also ensure that adverse event terms and other medical terms are properly coded into the global AE database. This ensures that reportable cases are processed within applicable timelines and with the relevant core safety information.
- How do you stay current with case handling standards, guidance documents, and database technology?
Answer: I regularly attend relevant training sessions and workshops, and I also keep up-to-date with the latest industry news and guidelines. I am a member of various industry associations, and I participate in online forums and discussion groups. I also regularly review guidance documents and other relevant resources to stay current with best practices.
- Can you describe a time when you had to compile a complete and accurate narrative summary of an adverse event?
Answer: In one case, I had to compile a complete and accurate narrative summary of an adverse event that occurred during a clinical trial. To do this, I reviewed all relevant medical conditions, lab results, and procedures, and then compiled a summary that accurately described the event and its potential impact on the patient. I also ensured that the narrative summary was in compliance with all relevant regulatory requirements.
- How do you work with departmental teams to maintain and upgrade the safety database?
Answer: I work closely with departmental teams to ensure that the safety database is up-to-date and functioning properly. This includes working with IT teams to troubleshoot any issues, as well as working with other safety team members to ensure that data is being entered accurately and efficiently. I also work with departmental teams to identify areas for improvement and to develop new protocols and guidelines for data entry.
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