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Junior Benefit Risk Management Lead 

POSITION PURPOSE:

The Junior Benefit Risk Management (BRM) Lead position belongs to the PV Regions Operations BRM and contributes to assure patients’ safety by complying with all PV Quality System Documents (QSDs) and national and international drug safety regulations and requirements.

The main purpose of the position is to ensure that Bayer Pharmacovigilance (PV) standards are met by performing and bringing expertise in PV benefit risk management activities.

YOUR TASKS AND RESPONSIBILITIES:

• Preparation of Aggregate Safety Reports, e.g. Periodic Benefit Risk Evaluation (PBRER) / Periodic Safety Update Reports (PSURs), Addendum Reports, Bridging Reports, etc.
• Preparation of Risk Management Plans (RMPs)
• Adapting global RMPs to local requirements
• Adapting global aggregate reports to local requirements
• Conducting local signal detection and management
• Supports handling of ad hoc NCA safety requests
• Supporting Due diligence and New drug development process
• Participation in BRM related cross-functional projects
• Liaises with the Country PV Functions in relation to PV legislative in BRM area and aligns on requirements interpretation
• Collaborates with global functions to assure effective and standardized set up of BRM processes
• Supporting preparation, roll-out and conduct of BRM trainings
• Supporting senior BRM team members in inspection and audit readiness preparation
• Ensures best practice, standardization and high compliance rates in Pharmacovigilance to assure the safety of patients and of company’s products
• Build and foster relationships through effective communication and collaboration between all internal and external stakeholders, while at the same time ensures that the highest PV standards are maintained
• Ensuring a high company compliance rate with respect to current legislation fulfilling the regulatory requirements and following the company QSDs for all activities covered by the PV Regions Operations BRM department

WHO YOU ARE:

• Medical, pharmacy or life science degree related to the area, preferably with 1-3 years’ experience in the Pharmaceutical industry, esp. in Pharmacovigilance
• Fluency in English (written and verbal communication)
• Team worker, able to work under tight timelines
• Very good communication skills
• Excellent organizational skills with the ability to find solutions (technical and non-technical) in a complex global and multicultural environment
• Excellent time management, focused on meeting deadlines
• Ability to follow and adhere to procedures and to make process improvement proposals
• Independent problem solving skills
• Knowledge of major concepts in data management and systems