Clarivate Drug Safety Content Specialist Job For MSc Biotech, Biochem, Life Sciences
Clarivate Drug Safety Content Specialist Job For MSc Biotech, Biochem, Life Sciences, Apply Online. MSc Biotech, Biophysics, Biochem, Microbiology and Life Sciences Job. Apply online for the Drug Safety Content Specialist vacancy at Clarivate. Interested and eligible applicants can check out all of the details on the same below:
Hey there, if you are interested in the role of Drug Safety Content Specialist
at Clarivate then make sure you check out some interview questions along with their answers that we have listed at the bottom of the page
Job Title: Drug Safety Content Specialist
Job Number: JREQ122055
City, ST: Noida, UP
Job Summary
We are looking for Drug Safety Content Specialist to join our Pharmacovigilance (PV) team (offices working in a Hybrid model). This is an amazing opportunity to support the team to perform literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.
Joining our team of PV Literature Screening, you will support the team in the analysis of Literature citations for individual case safety reports (ICSRs) as well as other
potential safety-relevant information impacting the risk-benefit and/or safety profile of customers’ products.About You – experience, education, skills, and accomplishments
- Master’s Degree in Life Sciences, Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.).
- A degree in Dentistry/physiotherapy/Nursing, which involves patient exposure in a hospital-based environment, would be an advantage
- At least 2 – 4 years of experience reviewing biomedical literature for adverse event reporting
- OR equivalent combination of education and experience (i.e., an information science degree with at least 2 years of relevant working knowledge of supporting drug and patient safety)
- Related experience in drug safety/ pharmacovigilance is desirable
- Strong analytic ability to analyze and summarize the main points of biomedical case reports, studies, or specific topics
- At least 2 years of experience using writing skills to support the creation of succinct, accurate, and precise summaries
- At least 2 years of working knowledge of biomedical terminology, drugs, and therapeutic areas
It would be great if you also had the following:
- Certification from a professional medical writer’s association
- Experience with commercial and client-specific biomedical literature databases
- Scientific/medical writing background
What will you be doing in this role?
- Critically analyses large numbers of articles from biomedical published literature and internal drug safety alerts and identifies individual case safety reports (ICSRs) as well as other potential safety-relevant information impacting the risk-benefit and/or safety profile of customer’s products, as per applicable regulatory requirements and standard operating procedures.
- Writes brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.
- Demonstrates understanding of client’s drug labels and uses that knowledge effectively when performing the safety assessments.
- Completes drug safety reviewing of each biomedical literature batch in a timely, thorough, and accurate manner in accordance with the client’s timeliness standards and quality.
- Uses a drug safety system to track all actions and assessments in an audit-ready reference history.
- Selects articles specific to the client’s interest for inclusion in the client’s product literature database per guidelines.
- Writes accurate, detailed, and complete abstracts of selected articles using good judgment regarding the level of detail required and excellent organization, grammar, and syntax.
- Extracts key points of articles and creates comprehensive and detailed indexes of the abstract contents to ensure precise and complete retrieval of literature from the client’s database.
- Ensures timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines.
- Maintains an awareness of new drugs and new therapeutic categories, new disease entities, and changes in biomedical terminology in the published literature.
About the Team
The PV Literature team supports multiple customers covering all therapeutic areas. It is a supportive working environment with personalized training, and opportunities to engage in different aspects of pharmacovigilance and participate in customer upgrade planning if desired.
Hours of Work
This is a full-time permanent position working weekdays (Monday to Friday)
At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training and other terms, conditions and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.
We know you are here all eager and wanting all of the answers, so read on below to read and absorb some of the interview questions for the role of Drug Safety Content Specialist at Clarivate
- Can you describe your experience with drug safety and pharmacovigilance regulations?
Answer: Yes, I have over 2-4 years of experience reviewing biomedical literature for adverse event reporting, and I have a Master’s Degree in Life Sciences. I am also familiar with pharmacovigilance regulations such as ICH guidelines, FDA, and EMA regulations. - How do you stay up-to-date with the latest developments in pharmacovigilance and biomedical terminology?
Answer: I stay up-to-date by attending relevant seminars and webinars, reading industry publications and journals, and networking with colleagues. I also frequently visit regulatory websites and databases to stay current with the latest regulations and guidelines. - Can you walk us through your experience using drug safety systems to track actions and assessments?
Answer: Yes, I have experience using drug safety systems to track all actions and assessments in an audit-ready reference history. I am able to manage and prioritize tasks, and ensure that each batch of literature is reviewed in a timely, thorough, and accurate manner in accordance with the client’s timeliness standards and quality. - How do you approach writing brief narratives summarizing ICSR criteria and other safety-relevant information in each article?
Answer: I approach this task by critically analyzing large numbers of articles from biomedical published literature and internal drug safety alerts. I identify individual case safety reports (ICSRs) as well as other potential safety-relevant information impacting the risk-benefit and/or safety profile of customer’s products. I then write succinct, accurate, and precise summaries of the ICSR criteria and other safety-relevant information in each article. - Have you worked with commercial and client-specific biomedical literature databases? If so, could you describe your experience?
Answer: Yes, I have experience with commercial and client-specific biomedical literature databases. I have worked with several databases, including PubMed, Embase, and Medline. I have also worked with client-specific databases, where I selected articles specific to the client’s interest for inclusion in the client’s product literature database per guidelines.
Editor’s Note: Clarivate Drug Safety Content Specialist Job For MSc Biotech, Biochem, Life Sciences. Please ensure that you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest in the industry. Follow us on our social media like Twitter, Telegram, Facebo
