Associate Director - Signal Management

Apolis; Cambridge (MA); Remote; USD 180,000 - 240,000; Part time

Job summary

Apolis is seeking an Associate Director of Signal Management & Innovation to lead global signal detection and management initiatives in a fully remote role. The position requires expert PV knowledge and cross-functional leadership to align with regulatory expectations across regions.

The role emphasizes mentorship, training, and oversight of vendors, with a focus on driving process improvements and robust safety signal evaluation across the organization.

Qualifications

• Requires hands-on Pharmacovigilance and signal detection/management experience.
• In-depth knowledge of PV regulations and EU PV expectations.
• Strong analytical and data presentation skills.
• Excellent technical writing, documentation, communication and presentation abilities.

Responsibilities

• Lead development, review, and maintenance of signal detection/management processes.
• Ensure compliance with global PV regulations and EU requirements.
• Serve as Signal Management SME across global and regional teams.
• Collaborate with Data Sciences, Regulatory Affairs, Medical Safety, and PSPV stakeholders.
• Represent Pharmacovigilance in cross-functional teams and external engagements.
• Design and deliver training programs on signal detection and management.
• Provide mentorship to junior Pharmacovigilance professionals.
• Oversee vendor-conducted signal management activities.
• Support process improvement initiatives within Signal Management & Innovation.
• Analyze and present complex safety data to support risk-benefit assessment.

Skills

Pharmacovigilance

Signal Detection

Regulatory compliance

Analytical skills

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences / Healthcare / Pharmacy / Medicine

Job description

Associate Director, Signal Management & Innovation

100% Remote

Contract Job

Business Unit: Research & Development

Job Description

We are looking for an experienced Pharmacovigilance / Signal Management professional to lead signal detection, evaluation, and management activities within a global pharmaceutical environment.

This role will serve as a Subject Matter Expert (SME) and partner closely with Global Regulatory Affairs, Data Sciences, Global Medical Safety, EU QPPV, PSPV, and external vendors to ensure signal management processes meet global regulatory and health authority expectations.

Key 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.

Required Qualifications & Skills

• 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 Background

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.