Job Description
Job Title 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
Required Qualifications & Skills
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.
apolis2024
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.
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.
apolis2024
Numbers & Facts
| Location | Cambridge, MA (Remote) |
| Industry | Computer/IT Services |
| Salary | $105–$110 Per Hour |
| Company Size | 500 to 999 employees |
| Website | https://www.apolisrises.com/ |
Benefits
Paid Sick Days, Employee Referral Program, Employee Events, Retirement / Pension Plans
About Company
Since 1996, RJT has provided successful SAP, Oracle, and IT consulting solutions and staffing services to clients around the world. The new Apolis brings you the same personalized service fortified with a greater array of IT solutions, global expertise, and cost-management strategies.
We are a global IT consultancy that seamlessly integrates experts and leading-edge solutions into your organization so you can focus on what really matters.
Skills
- Analysis Skillsunmatched
- Biologyunmatched
- Biotech and Pharmaceuticalunmatched
- Clinical Practices/Protocolsunmatched
- Communication Skillsunmatched
- Computer Systemsunmatched
- Cross-Functionalunmatched
- Data Scienceunmatched
- Establish Prioritiesunmatched
- Healthcareunmatched
- International Healthunmatched
- Maintain Complianceunmatched
- Medicineunmatched
- Mentoringunmatched
- Organizational Skillsunmatched
- Pharmacovigilanceunmatched
- Pharmacyunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Process Improvementunmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Research & Development (R&D)unmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Team Playerunmatched
- Technical Writingunmatched
- Training Program Developmentunmatched
- Training/Teachingunmatched
- Writing Skillsunmatched
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