Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Global Safety Leader Ophthalmology (m/f/d)
YOUR TASKS AND RESPONSIBILITES
- Be responsible for the safety assessment activities of assigned products in the therapeutic area ophthalmology and lead the pharmacovigilance benefit risk management processes including chairing safety management teams and benefit risk management teams
- Identify, prioritize and analyze clinical safety signals as well as ensure appropriate clinical safety risk communication and escalation
- Perform ongoing review of emerging safety data from various sources including single case reports, product technical complaints and published literature and reports from partner functions
- Work with the systems and operations teams to develop and continuously maintain and improve effective systems to ensure single cases fulfill the requirements for signal detection and aggregate report compilation through targeted training
- Produce high quality aggregate reports and responses to regulatory queries and ensure adequate labeling of safety related information as well as the effective and timely delivery of aggregate reports, benefit risk statements, safety sections of DCSI and relevant position paper and justification documents etc.
- Liaise with internal and external experts as well as key opinion leaders (KOLs) to obtain specialized medical expertise as appropriate
- Provide medical safety oversight of clinical study data in the context of the medical review process for clinical studies
- Plan and deploy skilled resources against project priorities in consultation with the head of pharmacovigilance benefit risk management
WHO YOU ARE
- Medical doctor (MD), PhD or equivalent medical degree with specialty certification being preferred; ophthalmology would be a great asset, but is not a must have
- Long-term professional experience in pharmaceutical industry, thereof several years of clinical and pharmacovigilance experience
- Appropriate experience with Regulatory Agency and KOL interactions as well as a good knowledge of pharmacovigilance relevant regulations and Bayer Pharma standards
- Proven evidence of effective delivery of high quality safety relevant documents as well as knowledge of relevant concepts in data management and systems, pharmacoepidemiology and statistics
- Strong influencing skills with the ability to explain and defend a position in the face of opposition
- High ability to solve problems and to structure and simplify complex tasks
- Fluency in English, both written and spoken
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 60901
Functional Area: Medical Affairs & Pharmacovigilance
Entry Level : Professional