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Director Of Pharmacovigilance Systems And Operations (Remote)

15+ years
Not Disclosed
10 Feb. 14, 2025
Job Description
Job Type: Full Time Education: RN, MS, MPH, PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director of Pharmacovigilance Systems and Operations (Remote)
Company: Roivant Sciences
Location: New York, NY, USA (Remote)

Company Overview:
Roivant Sciences aims to accelerate drug development by reducing time, cost, and risk in bringing new medicines to market. Since its founding in 2014, Roivant has established over 20 portfolio companies (Vants), achieved multiple successful IPOs, conducted positive phase 3 trials, secured FDA approvals, and formed global pharma partnerships. The company continues to build capabilities in drug discovery and development, striving to become a leading tech-enabled pharmaceutical company.

For more information, visit Roivant Sciences.

Position Summary:
The Director of Pharmacovigilance Systems and Operations will oversee Roivant’s safety management infrastructure, ensuring strategic and tactical execution. This role collaborates closely with regulatory and drug safety teams to manage safety systems for clinical drug development. The candidate must be a proactive and detail-oriented leader with expertise in safety management systems and pharmacovigilance operations.

Responsibilities:

  • Oversee Roivant's drug safety infrastructure and safety database systems, including validation and testing.
  • Collaborate with external vendors on safety case processing and systems management.
  • Develop and manage safety/pharmacovigilance (PV) processes and standard operating procedures (SOPs).
  • Work with Roivant’s drug safety team and subsidiary Vants to ensure proper handling of drug safety/PV responsibilities.
  • Ensure compliance with regulatory reporting requirements in collaboration with regulatory affairs.
  • Develop and manage pharmacovigilance agreements with external partners.
  • Assess clinical study-specific safety from study design to individual case reports.
  • Conduct due diligence for in-licensing opportunities from a drug safety/PV perspective.
  • Act as a subject matter expert on program and diligence teams.
  • Stay updated on global regulatory changes related to drug safety and pharmacovigilance.

Skills, Qualifications, and Requirements:

  • RN, MS, MPH, PharmD, or equivalent degree.
  • Minimum of 15 years of drug development experience in the pharmaceutical industry.
  • Experience with ArisGlobal LSMV and Veeva Vault systems preferred.
  • Expertise in implementing safety systems, including writing test scripts and acceptance testing.
  • Strong project management skills with a proactive and goal-oriented mindset.
  • Experience in global phase 1 to phase 3 clinical programs.
  • Ability to adapt and learn in a fast-paced, multi-program environment.
  • Strong knowledge of global clinical studies, PV processes, and regulatory reporting requirements.
  • Highly collaborative team player with excellent communication skills.
  • Capable of independent work and decision-making in a growing company.

Equal Employment Opportunity Statement:
Roivant Sciences provides equal employment opportunities and prohibits discrimination based on race, color, religion, age, sex, national origin, disability, genetics, veteran status, sexual orientation, gender identity, or any other protected characteristic.

Note: Roivant Sciences does not accept unsolicited resumes or outreach from agencies.