Senior Scientist, Risk Management – Safety Surveillance

This is a fully remote position, open to applicants in United States.

📋 Description

• Generate scheduled and on-demand aggregate safety reports, acting as the report owner for designated medium- to large-scale, standard-complexity reports.

• Maintain comprehensive product knowledge and assist in delivering on the objectives of the Safety Management Team.

• Organize and lead meetings, perform database searches, conduct aggregate safety analyses, review case-level details, and manage writing and coordination of strategic safety documents.

• Collaborate with team members, Medical Safety Officers, stakeholders, and vendors.

• Ensure the delivery of timely, high-quality reports and safety analyses.

• Work alongside the Therapeutic Area Safety Head, Medical Safety Officer, Safety Surveillance Physician, and other stakeholders to develop strategic approaches.

• Initiate, conduct, and supervise both internal and external database searches.

• Perform and/or lead the analysis of aggregate safety data and case-level reviews.

• Draft, contribute to, and coordinate essential safety deliverables.

• Ensure compliance with Pharmacovigilance Agreements and commitments related to assessment reports.

• Support the Safety Management Team and facilitate assigned Safety Management Team meetings.

• Offer guidance on the creation and updates of Risk Management Plans.

• Oversee the strategy for PBRER and review/align approvals for PBRERs, PSURs, DSURs, and other safety documentation.

• Address health authority inquiries and prepare comments for the Marketing Authorization Holder.

• Engage in labeling updates, signal validation and evaluation, safety-section updates for the Investigator’s Brochure, literature reviews, updates to the Product Safety Strategy, level 2 escalations, and cross-functional meetings.

• Identify and escalate potential safety concerns.

• Review comments and requests from regulatory assessors.

• Participate in cross-functional training, departmental meetings, training sessions, and initiatives.

⛳️ Requirements

• Bachelor's degree in Health or Biomedical Science with six to eight years of relevant industry experience, or equivalent.

• Alternatively, an advanced degree in Health or Biomedical Science with four to six years of relevant industry experience, or equivalent (advanced degree preferred).

• For Physicians (MD or equivalent), typically requires 2–5 years of pharmacovigilance or related experience; demonstrated clinical medicine skills with a preference for at least 3 years of clinical practice experience.

• Excellent verbal and written communication skills in English.

• Experience in clinical/medical writing or pharmacovigilance is preferred.

• Strong knowledge of drug development principles, drug risk-benefit assessments, safety evaluations for marketed and developing drugs, as well as global safety regulations is highly preferred.

🏝️ Benefits

• Permanent employment position.

• Opportunities for professional development.

• Excellent work-life balance.

• Quality-focused and collaborative “one-team” culture.

• Cross-functional training opportunities.

• Participation in departmental meetings and training sessions.

• Engagement in department and/or cross-functional initiatives.