Senior Pharmacovigilance Safety Scientist, Benefit Risk

This is a fully remote position, open to applicants in Serbia, +3 more countries.

📋 Description

• Prepare and conduct quality assessments of aggregate reports, including PSURs/PBRERs, PADERs/Annual Reports, ACO, and DSURs, for submission to Health Authorities.

• Develop and review Risk Management Plans as part of Pharmacovigilance initiatives.

• Draft and quality assess Signal Management Reports.

• Execute literature searches and conduct validity checks for aggregate reports.

• Oversee and reconcile relevant process trackers.

• Serve as a subject matter expert and provide training and mentorship to team members.

• Extract and verify data such as RSI, sales figures, previous reports, RMPs, and signals.

• Create Line Listings from the safety database and ensure their quality when necessary.

• Offer assistance for urgent ad-hoc tasks.

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

• Engage in internal and external audits or inspections as a subject matter expert when needed.

• Collaborate with client personnel to address issues related to assigned tasks.

• Ensure that client deliverables meet regulatory standards and are on schedule.

• Independently plan and carry out tasks such as preparing aggregate reports.

• Execute additional duties as required.

⛳️ Requirements

• Bachelor’s or Master’s Degree in Pharmacy, Nursing, Life Science, or a related health field, or an equivalent qualification/work experience.

• Over 4 years of experience in Pharmacovigilance with a particular emphasis on Risk Management Plans.

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

• Background in literature screening activities and/or the authoring and reviewing of aggregate reports.

• Experience in authoring and updating Risk Management Plans.

• Extensive knowledge of signal detection methodologies.

• Familiarity with managing CCDSs and understanding regulatory safety variation processes.

• Ability to communicate effectively with directors, management, PV Scientists, clients, and Health Authorities.

• Capability to coordinate tasks while maintaining high-quality standards.

🏝️ Benefits

• Support for remote working arrangements.

• Hybrid working model encouraged for new hires who are within a reasonable commuting distance to an office, as coordinated with their manager.

• Commitment to being an Equal Opportunity Employer.

• Dedication to diversity, equity, and inclusion.

• A safe and empowering workplace environment.

• Recruitment applications are personally reviewed by a member of the recruitment team.

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