VP/AVP - Life Science (Pharmacovigilance)

Location

Responsibilities

• Develop and implement Pharmacovigilance strategies to ensure compliance with regulatory requirements.
• Manage and oversee the collection, review, and reporting of Individual Case Safety Reports (ICSRs).
• Collaborate with cross-functional teams to ensure accurate and timely aggregate reporting.
• Detect and manage signals from safety data to ensure patient safety.
• Develop and maintain Pharmacovigilance policies and procedures.
• Provide medical review and oversight of Pharmacovigilance activities.
• Ensure compliance with Pharmacovigilance regulations and guidelines.

Requirements

• Bachelor's degree in Life Sciences or a related field.
• Minimum 16 years of experience in Pharmacovigilance, with a strong background in Pharmacovigilance regulations.
• Proven experience in ICSR management, aggregate reporting, and signal detection.
• Strong knowledge of Pharmacovigilance regulations, including ICH E2B, ICH E2C, and FDA regulations.
• Excellent communication and leadership skills.
• Ability to work in a fast-paced environment and prioritize multiple tasks.

Benefits

• Opportunity to work with a leading organization in the Life Sciences industry.
• Competitive salary and bonus structure.
• Comprehensive health insurance and retirement plan.
• Paid time off and holidays.
• Professional development opportunities.