inVentiv Health Sr. GSPV Physicians | Hyderabad / Pune in Hyderabad, India
Organization Overview inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 6,500 passionate employees supporting clients in more than 70 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
Like you, we are committed to enriching the lives of patients, families, and communities by helping to expedite the quality delivery of our clients’ therapies to market.
Title Sr. GSPV Physicians | Hyderabad / Pune
Job ID 13229
Responsibilities • Medical review of adverse events reported to investigational and marketed products including identification of event/s, confirmation of seriousness, ensure that events are coded and mapped to the appropriate terms in MedDRA, provide assessment of expectedness per reference safety information, assessment of causality, review of narrative for chronology and medical content and provide medical evaluation comment.
• Ensure that appropriate medical interpretation and consistency are applied to adverse event case assessment.
• Ensure regulatory compliance with respect to the evaluation, reporting and surveillance of safety information.
• Identify, communicate, and effectively manage potential safety issues.
• Provide medical safety analysis and interpretation for periodic safety aggregate reports (e.g. DSUR, PSUR/PBRER, PADER, bridging reports, and other relevant aggregate report/analyses).
• Interact with clients’ safety/medical personnel as appropriate to ensure above.
• Maintain a working knowledge of projects in the functional area for which inVentiv Health Clinical safety is responsible for safety reporting.
• Stay abreast of clinical and drug development information relevant to contracted programs by review of literature and by maintaining training.
• Serve as a mentor for other internal safety staff including case processing staff.
Requirements • MBBS/M.D., D.O., or equivalent degree from an accredited medical school
• Minimum 1-2 years experience in clinical practice
• Minimum 3-5 years experience in the pharmaceutical, biotechnology, CRO, or device industry working in pharmacovigilance performing medical review of individual cases.
• Knowledge of global pharmacovigilance regulations
• Excellent written and verbal communication skills
• Computer proficient
City Hyderabad / Pune
Country India [IN]