Associate Director, Pharmacovigilance Evaluation and Reporting (PVER) Scientist
Location:
Raritan , New Jersey
Posted:
April 02, 2017
Reference:
000019AR/4-en-us

Janssen Research & Development, LLC, a Johnson & Johnson Company, is currently recruiting for an Associate Director, Pharmacovigilance Evaluation and Reporting (PVER) Scientist, to be located in Horsham, PA, Titusville, NJ, High Wycombe, UK, or Raritan, NJ.

 

This is an individual contributor role, not a people manager role.

 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. 

 

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.  

 

We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.


The Associate Director, Pharmacovigilance Evaluation and Reporting Scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned products/reports. Scheduled reports include; PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR Addendum Reports. Non-scheduled reports include Ad hoc reports in response to health authority queries or internal requests, health hazard evaluations, and labelling support documents.

 
Principal Responsibilities:
  • Daily activities involve; lead strategy development for assigned reports, plan and conduct meetings, perform database searching, aggregate safety analysis and case level review, write assigned reports, manage complex projects and coordinate strategic safety documents, provide oversight of deliverables produced by other team members.
  • Have in-depth product knowledge, serve as product point of contact, and support Safety Management Team deliverables.
  • Partner with team members, stakeholders including Medical Safety Officer (MSOs), and a vendor. Function independently and have expert knowledge of applicable regulations and guidelines.
  • Strategically plan and ensure timely, quality reports/safety analyses related to core deliverables.
  • Collaborate with Therapeutic Area Safety Head (TASH)/MSO/Safety Surveillance Physician (SSP) and other stakeholders on strategy development for aggregate safety reporting.
  • Independently perform and/or lead aggregate safety analysis and case level review and write, contribute to, and coordinate the preparation of core safety deliverables.
  • Complete complex product reports where coordination and leadership of multiple scientists are required.
  • Ensure commitments (e.g., PV Agreements, assessment reports) are met.
  • Partner with vendor to develop reports/deliverables.
  • Work closely with management to proactively support Therapeutic Area related business.
  • May serve as Therapeutic Area Lead back up.
  • Provide enhanced Safety Management Team (SMT) support to enable proactive safety management and act as core member of the SMT for assigned products. 
  • Deliver innovative solutions for aggregate safety strategy and analyses and ensure high quality reports.
For the purpose of Training/Meetings/Audits/Inspections:
  • Participate in cross-functional training of relevant stakeholders.
  • Act as product or process Subject Matter Expert (SME) or departmental representative during audits/inspections.
  • Identify training needs and develop/execute training plan for department.
  • Lead department and/or cross-functional initiatives.
  • Work closely with team members to ensure a consistent approach to deliverables in the assigned therapeutic area and across department.
Decision-Making and Problem Solving:
  • Think strategically with respect to data interpretation and provide innovative solutions.
  • Recognize potential issues and or safety issues and escalate to the attention of the line manager or MSO.
  • Have the ability to understand nature of adverse drug reactions and complex associations.
  • Maintain a high level of flexibility, multi-tasking, and ability to (re)prioritize work of oneself and others. Have attention to detail and ability to analyze data in broader context.
  • Ability to work across multiple functions and therapeutic areas.
  • Review regulatory assessor comments/requests and accommodate/address as appropriate.

This position reports into the Pharmacovigilance Evaluation and Reporting Director, Therapeutic Area Lead.



Qualifications
  • A minimum of a Bachelor’s Degree in Health or Biomedical Science with 13+ years of industry experience or equivalent OR an Advanced Degree in Health or Biomedical Science with 9+ years industry experience or equivalent is required.  
  • A minimum of 3+ years of Clinical/Medical writing or PV experience required.
  • Fluent English verbal and written communication skills are required.
  • High proficiency in the analysis of large and/or complex aggregate data sets is required.  
  • Ability to develop in-depth knowledge of assigned products is required.
  • Knowledge of applicable global, regional, and local regulatory requirements (e.g., ICH guidelines) is required.  
  • Knowledge and experience in Oncology is preferred.
  • Ability to effectively present to cross-functional teams is required.

Primary Location
United States-Pennsylvania-Horsham
Other Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Science
Requisition ID
000019AR

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