Vivek Singh

About Vivek Singh

With over a decade in drug safety, I\'ve had the privilege of working across some of the…

Experience

1. Manager

   Cencora

   Nov 2022 — Present · Maharashtra, IN

   Project Manager & Pharmacovigilance Subject Matter Expert (SME)Performing activities1. Project Manager: Performing people management, guiding and successfully delivering the safety reports of major PV domain with good quality.2. Pharmacovigilance Monitoring: Monitoring and evaluating the safety of drugs during clinical trials and post-marketing phases to identify and assess any adverse events or safety concerns.3. Risk Assessment: Assessing the risks associated with the use of drugs by analyzing data from clinical trials, post-marketing surveillance, scientific literature, and regulatory reports.4. Signal Detection: Identifying signals of potential safety concerns or emerging risks based on data analysis and scientific literature review.5. Risk Management Planning: Developing risk management plans (RMPs) to mitigate identified risks and ensure the safe use of drugs, including the design and implementation of risk minimization strategies.6. Regulatory Compliance: Keeping abreast of relevant regulations, guidelines, and best practices related to drug safety, and ensuring compliance with applicable regulatory requirements.7. Risk Communication: Communicating safety-related information to healthcare professionals, patients, and other stakeholders through safety advisories, labeling updates, and educational materials.8. Benefit-Risk Assessment: Participating in benefit-risk assessments to support regulatory submissions, including New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and periodic safety update reports (PSURs).9. Post-Marketing Surveillance: Monitoring and analyzing post-marketing safety data to identify any new safety signals or trends that may impact the benefit-risk profile of drugs.

Education

• Mumbai University Mumbai

  Bachelor's degree, Dentistry

  2008 — 2012