Senior Director, Safety/Pharmacovigilance

Praxis Precision Medicines, Inc.

4h•Remote

About The Position

Praxis Precision Medicines, Inc. has an opening for a Senior Director, Safety/Pharmacovigilance in Boston, MA. 40 hours/week. 5% short-term travel, including up to 1% international travel and 4% domestic. Remote/telecommuting position, can work from anywhere within the U.S. DUTIES: Providing oversight and daily management of all activities pertaining to drug safety within the Praxis pharmacovigilance (PV) department globally. Includes: 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 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; and 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.

Responsibilities

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 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.