Key Responsibilities:
· Oversee all pharmacovigilance (PV) activities to ensure compliance with global regulatory requirements.
· Manage and monitor adverse event reporting and risk management for clinical trials and marketed products.
· Collaborate with cross-functional teams to support clinical trials and product development.
· Ensure timely and accurate submission of safety reports to regulatory authorities.
· Lead/Oversee post-marketing PV activities to ensure ongoing safety monitoring and compliance
· Develop and maintain PV systems, processes, and SOPs.
· Oversee pharmacovigilance vendors
· Provide medical expertise and support for product safety reviews and risk assessments.
Qualifications:
· MD, or PharmD.
· Minimum of 3 years’ experience in pharmacovigilance within the pharmaceutical industry.
· In-depth knowledge of pharmacovigilance regulations and guidelines (FDA, EMA, ICH).
· Excellent communication and leadership skills.
· Experience with clinical trials and post-marketing PV activities
· Ability to work in a fast-paced, collaborative environment.
· Oncology experience strongly preferred.
Preferred:
· Experience in a managerial role within the pharmaceutical industry.
· Familiarity with PV databases and global safety reporting systems.
· Knowledge of medical monitoring
