Benefit-Risk Excellence Lead, Senior PV Manager

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

📋 Description

• Execute short- and mid-term projects that foster innovation and excellence within the Benefit–Risk Assessment & Management (BRAMS) function.

• Improve processes and facilitate digital transformation, focusing on automation and AI enhancements.

• Spearhead transformational projects and assist in the implementation of project outcomes, including modifications to processes and standard operating procedures (SOPs) within signal detection and safety writing systems.

• Aid in governance, operating models, and prioritization of the portfolio.

• Align executive stakeholders and offer strategic decision-making support.

• Create transformation plans and develop roadmaps.

• Identify and escalate initiatives while managing associated risks.

• Oversee operations across the portfolio.

• Evaluate business cases.

• Assist in the mobilization of initiatives.

• Perform business analysis and gather requirements.

• Contribute to Signal Detection and Benefit-Risk initiatives.

• Assess and document existing processes.

• Convert business requirements into system and process specifications.

• Aid in reporting, visualization, and documentation tasks.

• Facilitate coordination between business stakeholders and technology teams.

• Organize and monitor workshops.

• Provide daily execution support.

⛳️ Requirements

• A relevant Bachelor's Degree in Life Sciences.

• Over 10 years of experience in the biopharmaceutical industry.

• Extensive hands-on knowledge in signal detection, safety writing, and risk management throughout the entire drug development lifecycle.

• In-depth understanding of global Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations, along with industry standards and evolving regulatory expectations.

• Proven experience in change leadership, including recognizing needs, designing and executing innovative solutions, guiding teams through transitions, and assessing outcomes.

• Demonstrated ability to adapt and remain resilient in dynamic or challenging situations.

• Exceptional verbal, written, and presentation communication skills.

• Strong proficiency in the English language.

• Capability to work independently, manage various priorities, and collaborate effectively within a matrixed organization.

🏝️ Benefits

• Full-time employment.

• Reasonable accommodations for individuals with disabilities during the application, interview, and employment process.

• Equal opportunity employment.