Medical Review Safety Physician Manager Lisboa

Overview

Join to apply for the Medical Review Safety Physician Manager role at Johnson & Johnson Innovative Medicine.

Johnson & Johnson is recruiting for a Medical Review Safety Physician Manager to be located in Lisbon, Portugal.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our
- based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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 single case signal detection activities for selected products as well as operational aspects of individual case medical review.

Responsibilities

• Active participation in MRSP activities which include, but are not limited to:
• Analysis and assessment of Critical Cases, including SUSARs
• Detection of single case potential safety signals/ through validation
• Identification and analysis of new safety signals and trends by conducting systematic reviews of aggregate data.
• Review local literature for potential signals assessed by vendors and Local Management Safety (LMS)
• Active participation in Signal Evaluation
• Ensuring Follow-up of all critical case/ Events of Special Interest (RMPs identified risks)
• PBRER/PADER activities
• Investigator Brochure activities
• Watchlist/TFUQ activities
• Vendor oversight activities as assigned
• Additional ad hoc activities that may require physician input, examples:
• Standard Operating Procedures (SOPs)
• CAPAs
• Audits/inspection activities
• Participation in pharmacovigilance
  - teams (i. e. Safety Management Teams) responsible for pharmacovigilance activities focused on products and therapeutic areas as assigned.
• Support GMS Product Team to drive change, increase efficiency, effectiveness and quality, and foster alignment, across GMS and with key stakeholders.
• Lead cross functional projects/teams, as assigned.

Requirements

• Physician (MD or equivalent) with a medical degree from a recognized medical institution.
• A minimum of 1 year of clinical practice after postgraduate training program 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.
• Experience and knowledge of Good Clinical Practices is strongly preferred.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Fluent in written and spoken English.
• Working knowledge of the use of Microsoft suite of software products, including Excel and Word.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact Ask
GS to be directed to your accommodation resource.