Director, Safety Surveillance Physician

Janssen Pharmaceutical Research & Development, L.L.C., a member of the Johnson & Johnson Family of Companies, is recruiting for a Director, Safety Surveillance Physician. This position will be based in Horsham, PA (preferred), Titusville, NJ or Raritan, NJ.

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 needsin 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 objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall Pharmacovigilance process. This includes aggregate signal detection activities for selected products, as well as the development of signal detection strategy. In addition, this position will also support oversight of vendors.

The Director, Safety Surveillance Physician (SSP) will provide pharmacovigilance expertise on individual case reports and single case signal management experience. The Director SSP will provide support to junior MSSI staff as needed and have focus on MSSI strategic activities such as signal detection methodology, ensuring medical review efficiencies, SUSAR strategies, and vendor oversight. The Director is expected to play a greater role as a senior strategic leader of internal and external business initiatives.

SSPs are responsible for the medical assessment of case level and aggregate safety data for new safety concerns and trends and ensure proper escalation to the head of MSSI and the TL SSP.

Principal Responsibilities

  • Perform medical review of single cases for assigned products
  • LeadProduct Teams for assigned products
  • Support SMT activities such as evaluating safety issues.
  • Provide single case expertise in the preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data.
  • Provide medical expertise in activities such as managing products or project teams.
  • Participate on cross-functional teams such as SOP committees, taskforces, work streams and representing GMSO positions, processes and guidance to external business partners
  • Perform signal detection activities for selected products (including but not limited to real-time signal detection, inter-product data mining, and lot alerts).
  • Perform validation of signals identified in reviews. Prepare summary analysis of safety data for the SMTs. Provide recommendations for further evaluation.
  • Vendor Oversight - Provide training and knowledge transfer as required and developing a working relationship aligned within the governance framework.
  • Contributing to the development and implementation of risk minimization action plans.

Decision-Making and Problem-Solving
  • Decision making centers around applying a thorough understanding of international pharmacovigilance regulations, GMSO SOPs and policies and procedures.
  • Identifying potential safety issues via aggregate signal detection methods and real time assessment of individual case safety review to identify potential safety concerns at the earliest stage possible to allow for the development of overall risk assessment strategies.
  • Use of applied epidemiologic principles and computer-assisted tools to detect new safety signals from thousands of safety reports received per year.
  • Make initial decision will be to determine whether there exists a potential risk to the treated population and to prioritize identified signals for systematic review and analysis. Based on a review of characteristics of a small series of cases, or based upon a statistical disproportionality compared to other drug/AE combinations, selected issues will be discussed with the Medical Safety Officer.

Qualifications
  • A Physician (MD or equivalent), is required. A Board Certification (if US) is preferred.
  • A minimum of 6 years of experience in industry, academia or patient care settings is required.
  • Direct experience in pharmacovigilance is strongly preferred
  • A minimum of 2 years in clinical practice after postgraduate training program is preferred.
  • Sound knowledge of general medicine and clinical practice, and the ability to assess the clinical relevance of medical data and to interpret its clinical meaning is required.
  • Experience and knowledge of Good Clinical Practices is required.
  • Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is strongly preferred.
  • Significant experience and judgment required to identify and evaluate issues likely to be relevant in understanding safety profiles of a large product portfolio is required.

Primary Location
United States-New Jersey-Raritan
Other Locations
North America-United States-Pennsylvania-Horsham, North America-United States-New Jersey-Titusville
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Science
Requisition ID
9537180112


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