O pozici
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Senior Benefit Risk Management Expert
The Senior BRM Expert position belongs to PV Benefit Risk Management and contributes to assuring patient safety by complying with all PV Quality System Documents (QSDs) and local and international regulatory requirements; As a Senior BRM Expert, you ensure that Bayer Pharmacovigilance (PV) standards are met by performing and bringing deep expertise in PV benefit–risk management activities; In this role, you collaborate closely with regional and global PV stakeholders, support inspection and audit readiness, and help drive best practices and standardization across the PV organization to safeguard patients and Bayer’s products.
Co budeš dělat
- Collaborate with the Sr. BRM Lead Regions in the oversight of BRM tasks and processes and independently manage BRM processes within your area of responsibility;
- Prepare, adapt and validate safety reports (e.g., Periodic Benefit Risk Evaluation Reports (PBRERs) / Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), Addendum and Bridging Reports) and manage safety report planning in line with global and local requirements;
- Oversee and conduct local signal detection and management, lead and prepare responses to ad hoc National Competent Authority (NCA) safety requests, and manage due diligence and new drug development–related BRM activities;
- Mentor junior team members in day‑to‑day operational activities, coordinate, prepare, roll out and conduct BRM trainings, and lead or actively contribute to BRM‑related cross‑functional projects;
- Negotiate and align with Country PV Functions on PV legislation and its interpretation in the BRM area, collaborate with global functions to ensure effective management of delegated BRM processes, and manage cooperation with external vendors;
- Drive inspection and audit readiness in collaboration with Sr. BRM Lead Regions, local/regional PV teams and global inspection management, participate in inspection and audit interviews, and ensure best practice, standardization and high compliance rates in Pharmacovigilance;
- Ensure delegated BRM tasks are correctly implemented and reflected in all relevant Standard Operating Procedures (SOPs), Working Procedures (WPs) and related documents, build and foster strong relationships with internal and external stakeholders, and secure high company compliance with current legislation, regulatory requirements and company QSDs for all activities.
Koho hledáme
- Medical or pharmaceutical degree (or closely related field) with at least 5 years’ experience in the pharmaceutical industry and a minimum of 4 years’ experience in Pharmacovigilance;
- Experience in leading functional teams in an international, cross‑functional environment, with strong independent problem‑solving skills and the ability to take personal accountability;
- Excellent knowledge of pharmacovigilance‑relevant regulations and solid understanding of major concepts in data management and systems, pharmacoepidemiology and statistics;
- Very good communication skills in English (written and verbal), able to communicate complex issues in an understandable, effective and relevant manner to diverse stakeholders;
- Strong team orientation combined with the ability to work independently under tight timelines, with excellent organizational and time‑management skills focused on meeting deadlines;
- Proven ability to follow and adhere to procedures while proactively identifying and proposing process improvements in a complex global and multicultural environment.
Benefity
- Bayer offers the possibility of working in a hybrid model. We know how important work-life balance is, so our employees can work from home, from the office or combine both work environments. The possibilities of using the hybrid model are each time discussed with the manager.
