Physician

• Perform medical review of adverse events for investigational and marketed products
• Apply medical interpretation and consistency to adverse event case assessment with Safety and Pharmacovigilance colleagues
• Ensure regulatory and SOP compliance for evaluation, reporting, and surveillance of safety information
• Identify, communicate, and manage potential safety issues
• Interact with client safety and medical personnel
• Stay current on clinical and drug development information relevant to contracted programs
• Provide medical review and interpretation for aggregate safety reports, including annual safety reports, PSURs, and PADERs
• Maintain medical and pharmacovigilance expertise through continued medical education
• Mentor and train internal safety staff, including case processing staff
• Perform activities in compliance with corporate and departmental policies, SOPs, work instructions, and project-specific operating guidelines
• Perform other duties assigned by management

Safety Physician

• Provide medical oversight of pharmacovigilance activities
• Ensure compliance with company SOPs, client directives, good clinical practice, and regulatory requirements
• Attend and present at sponsor meetings
• Provide medical and pharmacovigilance consultation to clients and project team members
• Support business development activities as needed
• Manage all medical aspects of contracted pharmacovigilance tasks across the pharmaceutical product life cycle
• Provide therapeutic and protocol training on assigned studies
• Write and/or review safety sections of CSRs, IND/NDA reports, ICSRs, signal detection reports, periodic reports, RMPs, REMS, and CTD modules
• Scientifically review aggregate reports, contribute to label updates, review literature, and support dossier maintenance and risk management activities
• Medically review cases and adverse events of special interest and serious adverse events
• Perform data reviews, including coding listings and full safety data, to assess potential safety concerns
• Review adverse event and serious adverse event data from solicited, spontaneous, and literature sources
• Identify and investigate safety signals
• Contribute to management of assigned products’ benefit-risk profiles

Physician jobs in India

Safety Physician

Pharmacovigilance Physician