Medical Director | Pune - 1 Opening(s)

Responsibilities:

• Manage a team of Physicians including 3 Managers and overall team of 20+ physicians
• Provide safety management and medical oversight of Pharmacovigilance activities as assigned.
• Identifies, communicates and effectively manages potential safety issues.
• Work closely with Pharmacovigilance colleagues to ensure appropriate medical interpretation and consistency are applied to adverse event case assessment
• Ensure regulatory and SOP compliance with respect to evaluation, reporting and surveillance of clinical safety information
• Provides Investigator support regarding safety concerns, medical emergencies, etc
• Participates in medical safety surveillance/signal detection benefit/risk assessment, and development of trend analyses
• Discusses and resolves medical issues with clinical sites, clients and drug safety staff
• Provide medical review and interpretation for aggregate safety reports (e.g. annual safety reports, PSURs, PADERs)
• Consult with internal and external customers in the area of drug safety.
• Supports business development through participation in core proposal team activities feasibility assessments and review of proposals/contracts for medical services.
• The post holder will perform necessary functions and as directed, any other duties commensurate with the post to ensure the smooth running of operation within the locations(s)
• This job description serves only to give a broad outline of the duties required and will be renewed and amended at periodic intervals in the consultation with the post holder.

Requirements

MBBS / M.D or equivalent degree from an accredited medical school

Currently licensed to practice medicine in one US state, or equivalent in other countries

Minimum 5 years experience in the pharmaceutical, biotechnology or device industry working in Pharmacovigilance/ epidemiology

Minimum 3 years of experience in managing team of physicians

Knowledge of global Pharmacovigilance regulations

Excellent written and verbal communication skills

Computer proficient

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