Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Global Medical Safety Operations Physician to be located in Horsham, PA; Raritan, NJ; High Wycombe, England; or Allschwil, Switzerland.

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The Associate Director, Global Medical Safety Operations Physician (GMSOP) is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process. The Associate Director will also provide medical expertise regarding the operational aspects of individual case medical review as well as oversight of vendor pharmacovigilance physician (PVP) activities. GMSOPs are responsible for the medical assessment of case level safety data for new safety concerns and trends and the communication to applicable Safety Management Team members. Additionally, the Assoc. Dr., GMSOP will participate in matrix management activities (e.g. Safety Management Team) and provide pharmacovigilance expertise on individual case reports.

The Associate Director, GMSOP will report to the Team Lead of the GMSOP group and work closely with him/her to ensure that the vision and strategy of the GMSOP group is implemented, as well as develop innovation and efficiencies within the GMSOP group.

The Associate Director will:

• Have responsibility for determining the medical and scientific relevance of adverse event reports within the context of the product’s safety profile including spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data.
• Perform Medical Review of:
  • Non-Suspected Unexpected Serious Adverse Reaction (SUSAR) clinical trial cases for products in development
  • Non-medically significant follow-up SUSARs
  • Business Partner SUSARs
  • SUSARs for non-company sponsored trials.
  • Spontaneous/ solicited individual case safety reports for products as assigned.
• Perform aggregate review of non-serious cases in line listings
• Evaluate Individual Case Safety Reports (ICSRs) for potential product quality issues (including device malfunctions, if applicable).
• Review and endorse automated tool for expedited reports to Health Authorities.
• Implement Targeted Follow-up Questionnaires
• Execute Investigator Brochure activities as assigned.
• Deliver Anticipated Events activities as assigned.
• All other operational activities that require physician input, example:
  • Standard Operating Procedures (SOPs),
  • CAPAs
  • Periodic Adverse Drug Experience Reports (PADERs)
  • Inspections and audits
• Perform oversight of vendor PVP activities

Qualifications

• A Physician (MD or equivalent), is required. A Board Certification (if US) is preferred.
• A minimum of 3 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.
• Good communication skills (written and verbal) and the ability to work in a team-oriented, matrix environment is required.
• Significant experience and judgment to identify and evaluate issues likely to be relevant in understanding safety profiles of a large product portfolio is required.

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.

The anticipated base pay range for this position is $154,000 to $266,800.

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.

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