Associate Director - Signal Management

Business Unit: Research & Development. 100% Remote Contract.

Responsibilities

• Lead the development, review, evaluation, and maintenance of signal detection and management processes.
• Ensure compliance with global pharmacovigilance regulations and EU regulatory requirements.
• Serve as a Signal Management/Detection SME across global and regional teams.
• Collaborate with Data Sciences, Regulatory Affairs, Medical Safety, and PSPV stakeholders.
• Represent Pharmacovigilance in cross-functional teams, committees, and relevant external engagements.
• Design and deliver training programs related to signal detection and management.
• Provide mentorship and guidance to junior/new Pharmacovigilance professionals.
• Lead and provide oversight of vendor-conducted signal management activities.
• Support process improvement initiatives and designated projects within Signal Management & Innovation.
• Analyze and present complex safety data to support informed risk-benefit assessment.

Requirements

• Bachelor’s degree in Life Sciences, Healthcare, Pharmacy, Medicine, or a related discipline.
• Strong hands-on experience in Pharmacovigilance and Signal Detection/Management.
• In-depth knowledge of PV regulations, clinical trial methodology, signal detection, and risk-benefit assessment.
• Experience working with global health authority and regulatory requirements, particularly EU PV expectations.
• Strong analytical skills with the ability to interpret and present complex safety data.
• Excellent technical writing, documentation, communication, and presentation skills.
• Strong critical thinking, strategic decision-making, and problem-solving capabilities.
• Ability to collaborate effectively within a global, cross-functional environment.
• Strong organizational and prioritization skills.
• Proficiency with relevant Pharmacovigilance, safety, data, and computer systems.

Preferred Qualifications

• Candidates with experience in Signal Management, Signal Detection, Drug Safety, Medical Safety, Pharmacovigilance, Risk Management, or Safety Sciences within the pharmaceutical, biotechnology, or healthcare industry are encouraged to apply.