Senior Pharmacovigilance Manager (Benefit Risk)

TL;DR

Senior Pharmacovigilance Manager (Benefit Risk): Leading benefit-risk teams to drive high-quality delivery of pharmacovigilance projects with an accent on signal detection and regulatory safety documentation. Focus on managing cross-functional teams, ensuring compliance with global PV regulations (EMA, FDA), and maintaining strong client relationships.

Location: Remote or Hybrid (Germany, Serbia, Sweden, Croatia, United Kingdom)

Company

hirify.global is a global provider of consulting solutions for biotech, medical device, and pharmaceutical organizations across the complete product lifecycle.

What you will do

• Lead and develop a high-performing signal detection team through line management, mentoring, and coaching.
• Coordinate signal detection, tracking, review meetings, and the evaluation of safety data.
• Oversee the delivery of aggregate safety reports, including PSURs, PBRERs, DSURs, and PADERs.
• Contribute to benefit-risk evaluations, Risk Management Plans (RMPs), and regulatory safety documents.
• Build and maintain strong relationships with clients and cross-functional teams to identify new business opportunities.
• Participate in audits and regulatory inspections while staying current with global PV regulations.

Requirements

• 7+ years of hands-on pharmacovigilance experience, with a strong focus on signal detection.
• Strong management background in team leadership and/or project management.
• Proven track record of successfully managing multiple client projects.
• Solid experience in signal evaluation and medical writing.
• Good working knowledge of global PV regulations (ICH-GCP, EMA, FDA, and other major authorities).

Culture & Benefits

• Commitment to diversity, equity, and inclusion, fostering a workplace where everyone can be their authentic self.
• Flexible work environment supporting remote work, with encouraged hybrid collaboration for those near office locations.
• Entrepreneurial and collaborative culture that empowers employees to innovate.
• Human-centric hiring process with personal review of all applications and no AI screening tools.