Medical Review Safety Physician - Manager (Oncology)
Lisbon, Portugal · Hybrid
Mid level
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Full-time
postgraduate degree
Posted 22d ago
Apply by Aug 15
~40 hrs/week
Responsibilities
The role involves providing medical expertise to evaluate safety data and detect signals as part of the Pharmacovigilance process. Responsibilities include analyzing critical cases, preparing aggregate safety reports, and participating in Safety Management Teams.
Requirements
Candidates must be a Physician (MD or equivalent) with at least 3 years of experience in industry, academia, or patient care. Fluency in English and a strong preference for pharmacovigilance and Good Clinical Practice experience are required.
Full job description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Product Safety
Job Sub Function:
Product Safety Risk Management MD
Job Category:
Scientific/Technology
All Job Posting Locations:
Lisbon, Portugal
Job Description:
Essential Job Duties and Responsibilities
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.
The Medical Review Safety Physician (MRSP) manager has responsibility for determining 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. Additionally, MRSPs participate in matrix management activities (e.g. Safety Management Team (SMT) and provide pharmacovigilance expertise on individual case reports. MRSPs 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/PADERs, ad-hoc regulatory reports, Risk Management Plans, and interpretation of surveillance and product quality data.
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 matrix-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.
Minimum Qualification
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.
Required Skills:
Preferred Skills:
Clinical Operations, Compliance Management, Compliance Risk, Critical Thinking, Cross-Functional Collaboration, Medicines and Device Development and Regulation, Organizing, Quality Control (QC), Research Ethics, Risk Management, Risk Management Framework, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Tactical Planning, Team Management
At Johnson & Johnson Innovative Medicine, we innovate with purpose, to lead where medicine is going. The experiences of patients around the world inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we confidently address the most complex diseases of our time and develop the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. https://bit.ly/3reuMvK
Health CareBiotechnologyMedicalManufacturingPharmaceutical
How many Security & Safety jobs are open in Lisbon, Portugal right now?
There are currently 282 open security & safety positions in Lisbon, Portugal listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Security & Safety roles in Lisbon, Portugal?
Companies currently hiring include Claranet Portugal, Inetum, VOIS, Devoteam, AgileEngine, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Security & Safety jobs in Lisbon, Portugal?
Yes — 170 of the 282 open security & safety positions offer remote or hybrid work (32 remote, 138 hybrid).
How do I apply for Security & Safety jobs in Lisbon, Portugal?
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