Senior Director, Safety/Pharmacovigilance at Praxis Precision Medicines, Inc.

, , United States -

Full Time

Start Date

Immediate

Expiry Date

30 Apr, 26

Salary

301159.0

Posted On

30 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Drug Safety, Regulatory Compliance, Safety Reporting, Risk Management, Audit Representation, Performance Monitoring, Cross-Functional Collaboration, NDA Preparation, Data Visualization, Signal Detection, Vendor Management, Post Marketing Surveillance, Clinical Trial Reporting, Case Processing, Leadership

Industry

Biotechnology Research

Description

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. MIN. REQ.: 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. SPECIAL REQ.: 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. PAY TRANSPARENCY: Wage ranges from $277,826 to $301,159/year. Apply on the Praxis Precision Medicines, Inc. career website: https://praxismedicines.com/#careers #LI-DNI #LI-DNP Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to careers@praxismedicines.com. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

Responsibilities

The Senior Director will oversee all activities related to drug safety within the pharmacovigilance department globally, including leadership of global operations and compliance. Responsibilities also include managing safety risks, ensuring inspection readiness, and collaborating on key safety deliverables.