Senior PV Scientist-Hybrid

Senior Pharmacovigilance (PV) Scientist

Join a leading biopharmaceutical organization as a Senior PV Scientist, where you'll play a pivotal role in ensuring patient safety and regulatory compliance across both investigational and marketed products. In this highly collaborative and analytical position, you will partner closely with the Safety Physician/Medical Monitor to lead global safety surveillance, signal management, and aggregate report authorship activities.

This role is ideal for an experienced PV professional who brings deep scientific understanding, strong project management capabilities, and the ability to synthesize complex clinical data into clear, actionable insights.

Safety Surveillance & Signal Management

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  Partner with the Safety Physician to coordinate and document ongoing safety surveillance, including signal detection, validation, and evaluation.

  
  
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  Analyze and interpret safety data from various sources to identify potential safety issues and trends.

  
  
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  Ensure timely and high-quality completion of safety deliverables in accordance with global regulations and SOPs.

  
  

Aggregate Reporting & Documentation

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  Lead authoring and management of aggregate reports such as PSURs, PADERs, and DSURs, including vendor oversight, data requests, statistical analyses, and quality review.

  
  
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  Support the development and maintenance of safety documentation (e.g., Investigator Brochure, Safety Monitoring Plans, Risk Management Plans).

  
  
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  Prepare materials for Safety Governance meetings and health authority interactions.

  
  

Cross-Functional Collaboration

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  Coordinate ad hoc safety queries, including responses to health authority requests, safety assessments, and internal escalations.

  
  
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  Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, Medical Affairs, and Quality to align safety data and risk management strategies.

  
  
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  Represent Safety in internal and external meetings, supporting safety strategy for both marketed and investigational products.

  
  

Clinical Trial Support (for Investigational Products)

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  Participate in protocol design, CRF/ICF review, and safety monitoring plan development.

  
  
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  Support DSMB presentations, SAE reconciliation, and data review activities.

  
  

Compliance & Continuous Improvement

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  Maintain up-to-date knowledge of global pharmacovigilance regulations and ensure compliance with company SOPs and industry best practices.

  
  
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  Contribute to process improvement initiatives and mentor junior PV Scientists in technical and operational excellence.

  
  

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  Minimum 5 years of relevant medical, scientific, or pharmaceutical experience, including at least 3 years in pharmacovigilance.

  
  
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  Proven experience leading signal detection, aggregate reporting, and safety data analysis activities.

  
  
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  Strong analytical and clinical judgment skills with the ability to interpret complex safety data.

  
  
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  Excellent written and verbal communication skills, with experience authoring regulatory and scientific documents.

  
  
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  Effective collaborator who can work both independently and cross-functionally in a fast-paced, matrixed environment.

  
  
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  Strong organizational and leadership skills, with experience managing projects and mentoring others.

  
  
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  Proficient in Argus, MedDRA, and standard business software (Excel, PowerPoint, Word).

  
  

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  Advanced degree required: PharmD, RN, MD, PhD, MPH, or NP.