01Overview
About the Role
Our client, a globally respected pharmaceutical company, is actively seeking a dedicated and experienced Senior Pharmacovigilance Specialist to join their safety monitoring team. This vital role, based in the vibrant city of Kochi, Kerala , will be instrumental in ensuring the safety and efficacy of pharmaceutical products through rigorous adverse event monitoring and reporting. The ideal candidate will possess a comprehensive understanding of pharmacovigilance principles, regulatory requirements, and case processing. This position offers a significant opportunity to contribute to patient safety and uphold the highest standards of drug safety surveillance within a leading pharmaceutical organization. We are looking for a meticulous and proactive professional with a strong commitment to pharmacovigilance best practices.
Key Responsibilities Collect, assess, and process adverse event reports from various sources in accordance with regulatory timelines and company SOPs. Ensure the accurate and timely reporting of safety information to regulatory authorities and internal stakeholders. Conduct medical literature reviews to identify potential safety signals and new safety information. Participate in the preparation and submission of periodic safety update reports (PSURs/PBRERs). Contribute to the development and maintenance of pharmacovigilance SOPs and work instructions. Support safety database management and ensure data quality and integrity. Collaborate with internal departments (e.g., Clinical Operations, Regulatory Affairs, Medical Affairs) on safety-related issues. Assist in the preparation for and response to regulatory inspections and audits. Stay up-to-date with global pharmacovigilance regulations and guidelines. Train and mentor junior pharmacovigilance staff as needed. Requirements Bachelor's or Master's degree in Pharmacy, Nursing, Life Sciences, or a related healthcare field. A minimum of 4-6 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry. In-depth knowledge of pharmacovigilance principles, GVP guidelines, and regulatory reporting requirements (e.g., FDA, EMA). Experience with safety databases (e.g., Argus, ArisG) and case processing activities. Proficiency in performing medical literature searches and signal detection activities. Excellent analytical, critical thinking, and problem-solving skills. Strong organizational skills and meticulous attention to detail. Effective written and verbal communication skills. Ability to work independently and as part of a team in a dynamic environment. Understanding of clinical trial safety reporting is a plus. Benefits Our client provides a competitive salary, performance incentives, and a comprehensive benefits package, including medical, dental, and vision insurance. Employees enjoy a generous paid time off policy, including vacation, sick leave, and holidays. We offer opportunities for professional growth through training programs, continuing education support, and attendance at relevant industry conferences. Retirement savings plans and life insurance are also provided. The work environment in Kochi is professional and collaborative, fostering a strong sense of team. This role offers a rewarding career path within a leading pharmaceutical company committed to ensuring drug safety and improving global public health. You will have the opportunity to work with cutting-edge safety systems and processes. .
