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Senior Manager, Pharmacovigilance (Pv) Operations Excellence

Lifelancer
LifeLancer
6+ years
Not Disclosed
10 Feb. 15, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Senior Manager, Pharmacovigilance (PV) Operations Excellence

Company: Lifelancer
Location: Cambridge, MA, USA (Remote)
Contract Type: Full-time
Seniority Level: Mid-Senior level

Company Overview:

Nuvalent specializes in chemistry-driven drug development to create selective medicines for cancer patients. Their team consists of experienced scientists and industry veterans dedicated to oncology drug discovery, development, and company building.

Role Overview:

The Senior Manager, PV Operations Excellence will report to the Senior Vice President of DSPV and play a key role in maintaining PV compliance, managing safety data presentations, standard PV procedures, and overseeing vendor services and PV agreements. The individual will collaborate cross-functionally and work with external safety teams, ensuring adherence to global pharmacovigilance regulations.

Responsibilities:

  • Support and develop GVP SOPs, strategies, processes, and training programs.
  • Assist in vendor audits, internal audits, and regulatory inspections, addressing GVP-audit findings.
  • Present GVP activities during regulatory inspections.
  • Review and support the maintenance of PSMF (Pharmacovigilance System Master File) and SDEA (Safety Data Exchange Agreements).
  • Track and escalate critical GVP findings to DSPV Senior Management.
  • Monitor key DSPV Performance Indicators (KPIs).
  • Develop, implement, and improve the DSPV Quality Management System.
  • Initiate deviations and CAPAs, conduct investigations, and perform root cause analysis.
  • Oversee the preparation and review of documents used in GVP activities.
  • Interpret and ensure compliance with global GVP regulations and guidelines.

Key Competencies:

  • Ability to collaborate, innovate, and integrate information from various sources.
  • Strong leadership, stakeholder management, and problem-solving skills.
  • Results-driven mindset, fostering a culture of continuous improvement.
  • Effective communication, presentation, and interpersonal skills.

Qualifications:

  • Bachelor’s degree in life sciences, healthcare, or related field (or equivalent experience).
  • 6+ years of industry experience, including 1-2 years in PV quality and compliance (GVP).
  • Experience in SOP development for GVP.
  • Knowledge of compliance and quality management systems, including deviations, CAPA management, KPIs, PV audits, and regulatory inspections.
  • Strong understanding of global safety/PV regulations (FDA, EMA, ICH).
  • Familiarity with PV processes, including case processing, signal detection, aggregate safety reporting, and clinical study safety management.

Equal Employment Opportunity (EEO):

Nuvalent provides equal employment opportunities and prohibits discrimination or harassment based on race, religion, sex, nationality, disability, or any other legally protected status.

For more details and to apply, visit: Lifelancer Job Posting