Pharmacovigilance Manager

The Manager of Pharmacovigilance is responsible for overseeing drug safety and risk management activities to ensure compliance with global regulatory requirements. This role involves monitoring, assessing, and reporting adverse events, ensuring patient safety, and maintaining compliance with applicable regulations and company policies. The ideal candidate will have a strong background in pharmacovigilance, regulatory affairs, and clinical safety.

Key Responsibilities:
• Manage and oversee all pharmacovigilance activities, including case processing, adverse event reporting, and risk management.
• Ensure compliance with global regulatory requirements, including FDA, EMA, and ICH guidelines.
• Conduct signal detection and risk assessment activities to identify potential safety concerns.
• Develop and implement pharmacovigilance policies, procedures, and standard operating procedures (SOPs).
• Prepare and review aggregate safety reports, including Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs).
• Collaborate with cross-functional teams, including regulatory affairs, clinical development, and medical affairs, to ensure safety-related concerns are addressed.
• Serve as a primary point of contact in REMS programs
• Monitor and analyze safety data to detect new safety signals and trends.
• Provide training and guidance to internal teams on pharmacovigilance regulations and best practices.
• Participate in audits and inspections to ensure pharmacovigilance compliance.
• Manage and coordinate Safety Data Exchange Agreements

Qualifications & Experience:
• Bachelor’s degree in pharmacy, Life Sciences, or a related field (Master’s or PharmD preferred).
• Minimum of 5 years of experience in pharmacovigilance, drug safety, or a related area.
• In-depth knowledge of global pharmacovigilance regulations and guidelines.
• Experience with pharmacovigilance databases and case processing.
• Strong analytical, problem-solving, and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office Suite and pharmacovigilance software.