Senior Scientist, Risk Management & Safety Surveillance

The scientist will be responsible for core safety deliverables including scheduled and ad hoc aggregate reports and will serve as report owner for assigned reports (medium to large volume, standard complexity). He/She will have in-depth product knowledge and will support Safety Management Team (SMT) deliverables as required.

Responsibilities

Ensure timely, quality reports/safety analyses related to core deliverables; Collaborate with Therapeutic Area Safety Head (TASH), MSO, Safety Surveillance Physician (SSP) and other stakeholders on strategy development; Initiate, conduct, and oversee searches of internal and external databases; Perform and/or lead aggregate safety analysis and case level review; Author, contribute, and coordinate the preparation of core safety deliverables; Ensure commitments (e.g., Pharmacovigilance Agreements and assessment reports) are met; Partner with vendor to develop reports/deliverables; Provide SMT support as needed; Act as ad hoc member for assigned products; Recognize potential safety issues and escalate to the report owner, line manager, or MSO; Review regulatory assessor comments/requests and accommodate/address as appropriate; Participate in cross-functional training, departmental meetings and initiatives; Lead SMT meetings for assigned products; Provide guidance on Risk management plans; Review PBRER/PSUR approvals; Support health authority queries; Participate in label working group for CCDS and prescribing information updates; Lead signal validation and evaluations; Support IB updates, DSURs, Clinical Overviews, Product Safety Strategy and Level 2 escalations/HHE

Requirements

Bachelor's degree in Health or Biomedical Science and six to eight years of industry experience or equivalent, or Advanced degree in Health or Biomedical Science and four to six years of industry experience or equivalent; Physician (MD or equivalent) generally requires 2-5 years of pharmacovigilance experience or other relevant experience (e.g., Clinical research, Medical Affairs); Strong English verbal and written communication skills

Nice to have

Advanced degree in Health or Biomedical Science; Clinical/medical writing or pharmacovigilance experience; Demonstrated knowledge of principles of drug development, assessment of drug risks and benefits, and safety assessment of drugs; Knowledge of global safety regulations; Demonstrated skills in clinical medicine with at least 3 years of clinical practice experience (physicians)