Full-Time

Director of Pharmacovigilance and Drug Safety Operations

Remote

Confirmed live in the last 24 hours

Roivant Sciences

Roivant Sciences

201-500 employees

Develops biopharmaceuticals and RNA therapeutics

Biotechnology
Healthcare

Expert

New York, NY, USA

Job location is in New York, but remote work is an option.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • RN, MS, MPH, PharmD or equivalent degree
  • Minimum 15 years of drug development experience in the pharmaceutical industry
  • Must have experience in phase 1 early stage programs through phase 3 late stage programs
  • Must have experience in global clinical studies and reporting requirements
  • Strong understanding of PV processes and quality requirements
  • Excellent verbal and written skills, allows for an open and effective dialogue throughout the company.
  • Experience with ArisGlobal LSMV and Veeva Vault systems is preferred
  • Must be able to command respect from peers and capable of highly independent work as well as being a team player and role model.
  • Must be a highly motivated, decisive, and results-oriented individual with the flexibility and creativity to excel in and contribute to a rapidly growing company.
  • Requires proven ability to manage multiple projects.
Responsibilities
  • Works with external vendors on safety case processing and systems management
  • Develops and implements when necessary drug safety/PV infrastructure and systems
  • Oversees and manages Roivant’s safety database system
  • Oversees safety processes and SOPs
  • Works with existing drug safety team at Roivant and at subsidiary Vants to insure all drug safety responsibilities are appropriately handled
  • Works closely with regulatory affairs at Roivant and/or at the subsidiary Vants to insure all drug safety regulatory reporting requirements are met
  • Responsible for developing and managing any pharmacovigilance agreements with external partners
  • Be able to assess clinical study specific safety, whether it is at the study design standpoint or at the level of a specific safety case report
  • Handle in-licensing due diligence from a drug safety/PV standpoint
  • Functions as the drug safety/pharmacovigilance subject matter expert on program and diligence teams
  • Keeps up to date on changing regulatory landscape as it applies to drug safety and pharmacovigilance

Roivant Sciences develops and delivers medicines and technologies aimed at improving patient health, focusing on drug candidates for genetic disorders and RNA therapeutics. The company operates in the biopharmaceutical market, which involves creating drugs from biological sources. Roivant's unique business model combines in-house development with strategic partnerships, allowing it to build a diverse pipeline of drug candidates. One of its key subsidiaries, Genevant, specializes in RNA therapeutics, utilizing proprietary delivery platforms for mRNA, RNAi, and gene editing to treat specific diseases. Roivant generates revenue through drug development, licensing agreements, and partnerships, with the goal of bringing innovative treatments to market efficiently.

Company Stage

N/A

Total Funding

$1.8B

Headquarters

New York City, New York

Founded

2014

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

-11%
Simplify Jobs

Simplify's Take

What believers are saying

  • Roivant's recent $7.1B deal with Roche to acquire Telavant highlights its strong potential for lucrative partnerships and significant financial growth.
  • The company's diverse pipeline, including promising RNA therapeutics and gene editing technologies, offers substantial opportunities for breakthrough treatments.
  • Strategic investments, such as the $2.02 million from Exchange Traded Concepts LLC, indicate strong investor confidence and financial stability.

What critics are saying

  • The failure of the lupus drug brepocitinib in Phase 2 trials underscores the inherent risks in drug development and potential setbacks.
  • Rumors of acquiring Immunovant, Inc. could lead to financial strain and integration challenges if not managed properly.

What makes Roivant Sciences unique

  • Roivant Sciences leverages a unique business model that combines in-house product development with strategic partnerships, setting it apart from traditional biopharmaceutical companies.
  • The company's focus on RNA therapeutics and genetic disorders, particularly through its subsidiary Genevant, positions it at the forefront of cutting-edge medical treatments.
  • Roivant's ability to rapidly advance its drug pipeline and form strategic alliances allows it to bring innovative treatments to market more quickly and efficiently than many competitors.

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