SERM Senior Scientist Role at GSK – Life Sciences Candidates Apply Online

GSK BSc Life Sciences Scientist Job – Apply Online

GSK BSc Life Sciences Scientist Job – Apply Online. SERM Senior Scientist Role at GSK – Life Sciences Candidates Apply Online. BSc, MSc & PhD life sciences SERM Senior Scientist job opening. Interested and eligible applicants can check out all of the details on the same below

SERM Senior Scientist role at GSK – Latest life science job – APPLY NOW

Role: SERM Senior Scientist

Location: Bengaluru, India

Category: Medical and Clinical

Req ID: 378010

Site Name: Bengaluru Luxor North Tower

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

APPLY ONLINE

Here are a few potential interview questions and answers for SERM Senior Scientist role at GSK :

1. Can you describe your experience with adverse event (AE) data collection and reporting in the context of clinical trials? Answer: Certainly. In my previous role, I’ve been extensively involved in the collection, processing, and reporting of adverse events for both marketed and investigational products. I’ve followed defined case handling procedures to accurately extract and enter AE data from various sources, including spontaneous reports from health professionals, sales representatives, consumers, and clinical trial reports. I’m well-versed in coding AE terms and medical terms into global databases, ensuring compliance with safety data exchange agreements and relevant regulatory requirements.

2. How do you ensure the accuracy and completeness of narrative summaries for adverse event cases? Answer: Ensuring accurate and complete narrative summaries is crucial. I meticulously interpret case-related information, including medical conditions, lab results, and procedures. I compile these details into comprehensive and accurate narrative summaries that provide a clear overview of the adverse event. This involves a deep understanding of medical terminology and the ability to effectively communicate the medical context surrounding the event.

3. Could you give an example of a situation where you had to handle a challenging or complex adverse event case? How did you approach it? Answer: Certainly. In one instance, I encountered a complex adverse event case involving multiple medical conditions and overlapping symptoms. To tackle this, I collaborated closely with medical professionals and reviewed relevant medical records to accurately assess the situation. I compiled a detailed narrative summary that highlighted the key aspects of the case and provided insights into the event’s causality. It required a combination of medical knowledge, attention to detail, and effective communication to navigate through the complexities and arrive at a comprehensive report.

4. How do you stay up-to-date with the evolving regulatory environment and safety data exchange agreements? Answer: Staying informed about regulatory changes is essential. I actively engage with industry publications, attend relevant conferences, and participate in continuous training programs. This allows me to remain current with case handling standards, guidance documents, and any updates to safety data exchange agreements. I also collaborate with colleagues and regulatory experts to share insights and knowledge, ensuring that our practices align with the latest requirements.

5. Can you describe a situation where you had to work collaboratively within a cross-functional team to maintain or upgrade a safety database? Answer: Certainly. In my previous role, I was part of a cross-functional team responsible for upgrading our safety database to align with the latest technology standards. I collaborated with IT professionals, database administrators, and other relevant stakeholders. I contributed by providing insights into the specific safety data requirements and workflows. By working together, we successfully implemented the necessary upgrades without disrupting our daily operations, ensuring a seamless transition to an improved database system.

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