Director, Safety Surveillance Physician (Oncology)

Auris Health

Auris Health

high wycombe, uk
Posted on Wednesday, September 13, 2023


Janssen Research & Development, LLC, is recruiting for a Director, Safety Surveillance Physician (SSP) to be located in Horsham, PA, Titusville, NJ, Raritan, NJ, Belgium or High Wycombe, UK.

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 the following therapeutic areas: immunology, oncology, neuroscience, infectious diseases & vaccines, cardiovascular & metabolism, and pulmonary hypertension. 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. We are guided by our Credo .

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

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.

The Director, Safety Surveillance Physician (Director, SSP) has primary responsibility to determine the medical and scientific relevance of adverse event reports within the context of the product’s safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.

The Director, SSP leads the medical assessment of case level and aggregate safety data for new safety concerns and trends and the communication of these issues to the SSP Team lead. Additionally, SSPs participate in matrix management activities (e.g. Safety Management Team) and provide pharmacovigilance expertise on individual case reports. SSPs support activities such as evaluating safety issues from various sources including Designated Medical Events (DME) and Events of Interest (EVOI), preparation of aggregate safety reports such as PBRERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data.

The Director, SSP has plays a meaningful role as a senior technical leader of internal and external business initiatives.

Principal Responsibilities:

  • Analysis and assessment of SUSARs and Critical Cases (DME, EVOI, etc.)
  • Detect single case signals/through validation
  • Core member of Safety Management Team
  • Actively participate in Signal Evaluation
  • Ensure Follow-up of all critical case/ Events of Special Interest (RMP identified risks)
  • PBRER activities as needed
  • Investigator Brochure activities


Required Education & Experience :

  • A Physician (MD or equivalent), is required.

Preferred Experience Requirements:

  • Board Certification (if US).
  • A minimum of 6 years of experience in industry, academia or patient care settings = (may include Residency training and Fellowship training).
  • Direct experience in pharmacovigilance including knowledge of pharmacovigilance regulatory requirements in US, the EU and globally.
  • A minimum of 2 years in clinical practice after postgraduate training program.
  • Experience and knowledge of Good Clinical Practices.
  • 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 critical. Strong communication skills (written and verbal) and the ability to work in a team-oriented, matrix environment is necessary. Significant experience and judgment required to identify and evaluate issues likely to be relevant in understanding safety profiles of a large product portfolio.
  • The successful candidate will have strong leadership, teamwork, and interpersonal skills.
  • Specialized knowledge and experience in oncology is highly desirable.

The anticipated base pay range for this position is $186,000 to $322,000.

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .