Consultant, Pharmacovigilance
2 months ago
Clarivate is looking for an experienced Pharmacovigilance Consultant to join a fully remote international team, reporting to the Manager for Operations & Analysis. This role will be responsible for conducting analytical research to support the needs of customers.
- About You - experience, education, skills, and accomplishments-
- Bachelor’s degree in life science or healthcare-related field
- At least 2 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)
Strong analytic ability to analyze and summarize the main points of biomedical case reports, studies, or specific topics
- At least 1 year of experience using writing skills to support the creation of succinct, accurate, and precise summaries
- At least 1 year of working knowledge of biomedical terminology, drugs, and therapeutic areas- It would be great if you also had-
- Master’s degree or higher in Nursing, Pharmacy, Medicine, or related discipline
- Certification from a professional medical writer’s association
- Experience with commercial and client-specific biomedical literature databases
- Science/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 fully remote international team of Pharmacovigilance Specialists 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 remote, full-time, permanent position working weekdays (Monday to Friday) with scheduling flexibility around core working hours.
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