Senior Pharmacovigilance Safety Scientist, Benefit Risk

This is a fully remote position, open to applicants in Germany, +4 more countries.

📋 Description

• Create and conduct quality reviews of aggregate reports, including PSURs/PBRERs, PADERs/Annual Reports, ACO, and DSURs for submission to health authorities.

• Draft and review Risk Management Plans (RMPs).

• Write and conduct quality checks on Signal Management Reports.

• Conduct literature searches and validity assessments for aggregate reports.

• Manage and reconcile relevant process trackers.

• Act as a subject matter expert while providing training and mentorship to individuals.

• Extract and validate data, including RSI, sales figures, previous reports, RMPs, and signals.

• Generate Line Listings from the safety database and perform quality checks as necessary.

• Offer reliable support for urgent ad-hoc activities.

• Conduct literature validity checks and duplicate searches using the appropriate tools.

• Participate in internal and external audits and inspections as a subject matter expert when required.

• Communicate with client personnel to resolve issues related to assigned tasks.

• Ensure that client deliverables adhere to relevant regulatory standards and timelines.

• Independently plan and execute tasks such as the preparation of aggregate reports.

• Coordinate with directors and management while overseeing the work of PV Scientists.

• Set a positive example and maintain the company's quality standards.

⛳️ Requirements

• Over 5 years of experience in Pharmacovigilance with a focus on Risk Management Plans.

• Bachelor’s or Master’s Degree in Pharmacy, Nursing, Life Sciences, or another health-related field, or equivalent qualification/work experience.

• Proven experience in presenting metrics and leading quality discussions with internal teams and clients.

• Familiarity with literature screening processes and/or authoring and reviewing aggregate reports.

• Experience in authoring and updating Risk Management Plans.

• In-depth knowledge of signal detection methodologies.

• Experience managing CCDSs.

• Understanding of regulatory safety variation processes.

🏝️ Benefits

• Support for remote working arrangements.

• Hybrid working options encouraged for new hires residing near an office.

• Commitment to diversity, equity, and inclusion.

• A safe and empowering work environment.

• Applications are personally reviewed by the recruitment team.

• Applicants will receive feedback regarding the outcome of their application.