Clarivate is a global leader in providing trusted information and insights to accelerate the pace of innovation. With a strong commitment to supporting life sciences and healthcare industries, we offer comprehensive solutions to enhance drug safety and efficacy. Our pharmacovigilance team operates with a focus on delivering high-quality literature search services to clients worldwide, ensuring timely reporting and thorough analysis of adverse events in various therapeutic areas. We are currently searching for a dedicated Senior Pharmacovigilance Specialist to join our team in Karnataka, India.
Responsibilities in Job
As a Senior Pharmacovigilance Specialist – Search Services, you will play a crucial role in conducting specialized biomedical literature searches. Your responsibilities will include:
- Developing Search Strategies: Design and refine comprehensive literature search methodologies using databases such as MEDLINE, Embase, and Biosis Previews to ensure systematic screening of scientific literature.
- Adverse Event Reporting: Conduct in-depth literature searches for New Drug Applications (NDA), Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR), and client-requested searches to identify critical safety information.
- Training and Mentorship: Support the development and execution of a training program for new team members, conducting regular training sessions, and assessing trainee performance to ensure compliance with internal guidelines and documentation practices.
- Client Collaboration: Engage with clients during the pre-and post-sales process to understand their specific needs and provide tailored solutions.
- Staying Updated: Maintain awareness of new drugs, therapeutic areas, disease entities, and evolving biomedical terminology to ensure responsiveness to the requirements of the department.
Qualifications
To be successful in this role, candidates should possess the following qualifications:
- A Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Nursing, Chemistry, Information Sciences, or a related field; an advanced degree (e.g., PharmD, MD, PhD) is preferred.
- A minimum of 5 years of experience in reviewing biomedical literature specifically for adverse event reporting, with expertise in literature screening.
- Proficient writing skills for creating concise and accurate summaries, along with a strong understanding of biomedical terminology, drugs, and therapeutic areas.
Skills
Successful candidates should also demonstrate the following skills:
- In-depth Knowledge of Pharmacovigilance: Strong understanding of pharmacovigilance principles, adverse event reporting requirements, signal detection methodologies, and risk assessment principles.
- Regulatory Familiarity: Knowledge of pharmacovigilance regulations and guidelines, including ICH and GVP, along with experience in regulatory submissions.
- Literature Searching Expertise: Proficiency in using biomedical searching platforms (e.g., Dialog, PubMed) and applying thesauri such as MeSH and Emtree.
- Collaborative Mindset: Ability to work effectively with colleagues and clients to ensure best practices are adhered to and optimal solutions are implemented.
