Pharmacovigilance Associate

Pharmacovigilance Associate

Posted by Centric Edu

Hyderabad,Navi Mumbai,Bengaluru

Posted: imported by Jeevika

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Hyderabad, Navi Mumbai, BengaluruPosted: 2 weeks agoOpenings: 50Applicants: 100+Pharmacovigilance AssociateCentric EduJob description Role & responsibilities Perform Individual Case Safety Report (ICSR) processing, including case intake, data entry, validation, and follow-up. Review and assess adverse event reports from clinical trials, spontaneous sources, literature, and other safety databases. Perform case coding using MedDRA and WHO Drug/appropriate coding dictionaries. Conduct seriousness, expectedness, and causality assessments as per applicable procedures and guidelines. Prepare and submit safety reports within defined regulatory timelines. Perform duplicate checks, quality review, and data reconciliation to ensure accuracy and completeness. Support follow-up activities for missing or incomplete safety information. Maintain accurate documentation and comply with SOPs, GVP guidelines, and regulatory requirements. Assist with aggregate safety reporting, signal detection, and safety data analysis as required. Collaborate with Clinical, Regulatory Affairs, Medical Writing, and other cross-functional teams. Ensure compliance with applicable global pharmacovigilance regulations and company quality standards.Preferred candidate profile Bachelors or Masters degree in Pharmacy, Life Sciences, Medicine, Biotechnology, Nursing, or a related field. 03 years of experience in Pharmacovigilance/Drug Safety is preferred; freshers with relevant PV training may also be considered. Good understanding of Pharmacovigilance principles, ICSR processing, adverse event reporting, and safety databases. Knowledge of MedDRA coding and case processing workflows is an advantage. Familiarity with GVP guidelines, ICH guidelines, and regulatory reporting requirements. Experience or training in Argus Safety, Medidata Rave, or other pharmacovigilance databases is preferred. Strong attention to detail and ability to work accurately with safety data. Good written and verbal communication skills. Ability to manage multiple cases and meet strict regulatory timelines. Good analytical, documentation, and problem-solving skills. Willingness to work in a team-oriented and process-driven environment.You can share your updated Cv in whatsapp to HR Shruti [hidden] or HR Riya [hidden]Role: Healthcare & Life Sciences - Other,Industry Type: Education / Training,Department: Healthcare & Life Sciences,Employment Type: Full Time, PermanentRole Category: Healthcare & Life Sciences - OtherEducationUG: Any GraduateKey SkillsSkills highlighted with ‘‘ are preferred keyskillsPharmacovigilanceLife SciencesHealthcare DomainClinical ResearchPharmacyDrug SafetyClinicalCase ProcessingMedicalPharmaceuticalAbout companyCentric EduFocus on healthcare/clinical research domain: Unlike generic training firms, Centric Edu emphasises healthcaresector training which can be attractive if you are looking for roles in life sciences, clinical data, research design etc.Industryexpert curriculum: With over 650 industry experts claimed to contribute, the curriculum likely reflects current needs and trends in the healthcare/clinical research domain.Handson, projectbased learning: Realtime projects are an added differentiator which helps students bridge theory to practice.Contact Number:[hidden]Company InfoAddress:71 ASHOKA NAGAR Arumbakkam Chennai Chennai Arumbak kam Chennai Tamil Nadu India 600106, Chennai, Tamilnadu, IndiaBeware of imposters! Naukri.com does not promise a job or an interview in exchange of money. 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