Signal Management Professional

The Fountain Group; Cambridge (MA); Remote; USD 100,000 - 125,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Director/Senior Associate for Signal Management. This role involves ensuring compliance with international pharmacovigilance standards, leading signal detection efforts, and overseeing the development of innovative safety monitoring processes. The ideal candidate will possess advanced medical degrees and extensive experience in drug safety and regulatory affairs, contributing to the company's commitment to patient safety.

Qualifications

• 5+ years of experience in global Pharmacovigilance (PV) in the EU and US.
• Experience preparing responses to Regulatory Authorities.
• Technically competent to develop and maintain signal detection processes.

Responsibilities

• Lead signal detection, evaluation, and management processes.
• Ensure compliance with EU regulations and ICH/GCP guidelines.
• Act as subject matter expert in cross-functional teams.

Skills

Medical drug safety assessments

Drug safety surveillance and monitoring

Preparation of aggregate reports

Regulatory submissions experience

Education

MD, PhD, PharmD, NP, PA, or nursing degree

Job description

Title:Signal Management (Director / Senior Associate)
Contract: 8-month contract, potential for extension
Remote position:9am-5pm EST Hours (Global Team)
Pay: $60-64 hourly, depending on experience level

Qualifications:

• MD, PhD, PharmD, NP, PA, or nursing degree with 5+ years of experience in global Pharmacovigilance (PV) - EU and US
• Medical drug safety assessments, drug safety surveillance and monitoring activities.
• Experience with the preparation of aggregate reports (DSUR, PSUR/PBRER, PADER).
• Experience with preparation of responses to Regulatory Authorities, preferred experience with IND/NDA submissions and negotiations with Regulatory Authorities as part of marketing approval.

Job Description:

• Ensures signal detection, evaluation and management processes meet highest standards by working cross functionally and leading the development of required processes (e.g., with Global Regulatory Affairs, Data Sciences).
• Ensures that Signal Management processes and activities are compliant with EU regulations and EU regulatory authority and inspectors’ expectations.
• Technically fully competent to develop, review, evaluate and maintain the signal detection and management processes in line with regulations and in close liaison with the business units, including Data Sciences as well as internal PSPV stakeholders.
• Represents the pharmacovigilance department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required.
• Ensure compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure patient safety for company’s products.
• Ensure patient safety for company’s products and maintenance of compliance with the Pharmacovigilance regulations of Regulatory Agencies around the globe.
• Represent all activities related to pharmacovigilance, clinical safety, risk management and signal detection, and report back relevant information regarding status, issues, and/or challenges.
• Strategize and align with the GSLs in developing data analysis strategies and in generating outputs using suitable Pharmacovigilance database retrieval strategies.
• Create visualizations in the form of graphics and tables for regulatory reporting, internal safety updates, signal evaluations and other analysis purposes and product-specific matters.
• Provide input to safety documents and reports to submitted to regulatory authorities.
• Supports inspections and audits related to Signal Management and associated commitments.
• Leads interactions with other PSPV functions including EU QPPV and Global Medical Safety to ensure processes are regularly updated and are fit for purpose.
• Leads interactions with other relevant functional areas both within and outside of PSPV to ensure standards are maintained.
• Participate in training sessions, workshops, and/or conferences, and share knowledge with team members, as agreed.
• Leads training for PSPV and other relevant functions on signal detection processes to ensure training and compliance with processes are maintained.
• Leads interactions and oversight of signal management activities conducted by any vendor.
• Leads interactions with other relevant functional areas both within and outside of PSPV to ensure standards are maintained.
• Designs and delivers relevant training as appropriate.
• Provides mentorship and guidance for junior/new pharmacovigilance scientists, interns/fellows, and others as appropriate.
• Lead current projects and innovative opportunities by providing subject matter expertise and technical support.
• Design, drive, and promote novel advanced analytical tools building the next generation of safety capabilities by delivering value adding benefit/risk information.
• Actively lead teams and guide team members to develop and integrate innovative solutions for AI/ML applications and other digital strategies.