Pharmacovigilance and Drug Safety Senior Manager

• Minimum of 6 years of pharmaceutical industry experience.
• Minimum of 3 years of direct Pharmacovigilance experience.
• Strong knowledge of FDA, EU, and ICH regulations and guidelines governing clinical trial and post-marketing safety.
• Hands-on experience with ICSR and case processing activities, including adverse event intake, triage, review, and reporting.
• Demonstrated knowledge of pharmacovigilance systems, safety surveillance, and risk management practices.
• Experience developing and maintaining pharmacovigilance processes and documentation.
• Excellent written and verbal communication skills.
• Strong ability to collaborate across multidisciplinary teams.

• Knowledge of MedDRA terminology and coding practices.
• Experience reviewing cumulative safety data and identifying emerging safety signals.
• Ability to interpret, synthesize, and communicate complex clinical and safety information.
• Experience authoring and reviewing safety reports.
• Familiarity with FAERS and EudraVigilance systems.
• Thorough understanding of the drug development lifecycle and safety surveillance activities.
• Experience supporting NDA and MAA submissions.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
• Excellent analytical, problem-solving, and decision-making skills.
• Ability to work independently while maintaining strong collaboration with cross-functional teams.
• Highly motivated, detail-oriented, and committed to continuous learning.

We are seeking an experienced Pharmacovigilance and Drug Safety Senior Manager to lead and support pharmacovigilance activities across clinical development programs. This role will be responsible for ensuring compliance with global pharmacovigilance regulations, overseeing safety operations, managing safety data, supporting regulatory submissions, and collaborating cross-functionally with clinical and regulatory teams.

The ideal candidate will have extensive experience in pharmacovigilance operations, safety reporting, risk management, and regulatory compliance within both clinical trial and post-marketing environments.

• Lead or contribute to the development and maintenance of pharmacovigilance processes, procedures, and systems to ensure compliance with applicable regulations.
• Oversee case processing activities, including:
  • Adverse Event (AE) intake and triage
  • Serious Adverse Event (SAE) review
  • Individual Case Safety Report (ICSR) preparation and review
  • SUSAR reporting
  • Timely submission of safety reports to regulatory authorities
• Ensure accuracy, completeness, and quality of safety data collection and reporting.

• Oversee configuration, maintenance, and quality control of pharmacovigilance safety databases.
• Ensure accurate data entry and reconciliation with clinical databases.
• Support the timely generation of safety reports and regulatory submissions.

• Prepare and review Safety Management Plans (SMPs), Pharmacovigilance SOPs, and periodic safety reports, including DSURs.
• Represent Pharmacovigilance and Drug Safety on clinical study teams.
• Collaborate cross-functionally to ensure achievement of study and safety objectives.
• Participate in SAE reconciliation, coding reviews, and other study team activities.
• Provide pharmacovigilance input during protocol development to ensure appropriate collection of safety data.
• Review study-related documents including:
  • Investigator Brochures (IB)
  • Informed Consent Forms (ICF)
  • Study Charters
  • Clinical Study Reports (CSR)

• Support pharmacovigilance inspections and audit activities.
• Contribute to regulatory submissions and reviews, including:
  • INDs
  • NDAs
  • MAAs
• Assist in preparing responses to regulatory authority questions and requests.
• Ensure compliance with FDA, EMA, ICH, and other applicable global pharmacovigilance requirements.