Senior Director, Safety/Pharmacovigilance
Praxis
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $277,826 - $301,159 per year
Job Level
About the role
- Providing oversight and daily management of all activities pertaining to drug safety within the Praxis pharmacovigilance (PV) department globally.
- Leadership and oversight of global PV operations, personnel and strategic resource planning.
- Oversight of developing compliant PV procedures and training modules.
- Oversight of timely safety reporting to regulatory authorities and external business partners.
- Implementation of strategies to manage safety risks.
- Ensure the PV department maintains inspection readiness, including representing the company during audits and pharmacovigilance inspections.
- Monitor key performance indicators for PV vendors.
- Collaborate cross-functionally to ensure timely authoring of key safety deliverables including periodic safety updates and regulatory query responses.
- Lead PV/safety aspects of NDA/MAA preparation, including authoring of integrated safety summary and drafting labeling.
- Leads capabilities enhancement within PV, including implementation of safety database and data visualization tools for signal detection.
- Oversight of relationships with external business partners, including overseeing the alliance, associated requests, and PV agreements, ensuring mechanisms are in place for governance of partnerships.
Requirements
- MD, DO, PharmD, PhD, or foreign equivalent in Medicine, Pharmacy, or related clinical field, such as Epidemiology or Public Health.
- 8 years of experience in a Pharmacovigilance role within the Pharmaceutical / Biotechnology industry.
- 8 years of experience ensuring PV procedures remain compliant with regulatory guidance by maintaining knowledge of good Pharmacovigilance practices and the evolving regulatory landscape.
- 8 years of experience in pharmacovigilance case processing, including case management, and individual and aggregate case reporting.
- 8 years leading PV operations, including oversight of third-party vendors.
- 4 years of experience implementing post marketing and clinical trial safety surveillance and reporting requirements.
- 1-year minimum experience implementing post marketing and clinical trial safety surveillance and reporting requirements in decentralized trials.
- 4 years of experience interacting externally and internally to support the scientific and business strategy.
- 3 years of experience managing PV for small molecules and antisense oligonucleotides, for both rare and prevalent diseases.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmacovigilancesafety reportingcase processingcase managementindividual case reportingaggregate case reportingsafety surveillancesignal detectionregulatory compliancedata visualization
Soft Skills
leadershipcollaborationstrategic planningoversightcommunicationrelationship managementgovernancemonitoringtrainingproblem-solving
Certifications
MDDOPharmDPhDEpidemiologyPublic Health