Medical Review Safety Physician - Manager; Oncology

Product Safety Risk Management MD

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