Pharmacovigilance Manager (PV I)

About the role

The Pharmacovigilance Manager (PV I) will lead drug safety surveillance programmes, ensuring product integrity and patient safety throughout clinical development and post‑marketing phases. This role combines strategic oversight with hands‑on assessment of safety data to support regulatory compliance and risk mitigation.

Key responsibilities

• Oversee drug safety surveillance activities across clinical trials and post‑marketing programmes.
• Conduct safety signal detection, risk assessments and develop mitigation strategies.
• Ensure compliance with governmental regulations, participate in audits and inspections.
• Provide safety expertise to clinical development teams and guide safety‑related decisions.
• Review adverse reaction reports, perform follow‑ups and ensure thorough investigations.
• Design and implement lifecycle safety surveillance plans aligned with company objectives and regulatory expectations.

Required profile

• Bachelor’s degree in Pharmacy, Medicine, Life Sciences or related field; advanced degree preferred.
• Minimum 5 years of experience in pharmacovigilance, drug safety, clinical trial safety oversight or post‑marketing surveillance.
• Strong knowledge of governmental regulations and risk‑management strategies.

Required skills

• Expertise in pharmacovigilance and drug safety processes.
• Ability to analyse complex safety data and identify trends.
• Proficiency in regulatory compliance and audit preparation.
• Experience in risk assessment and mitigation throughout product lifecycle.