Your tasks and responsibilities
Bayer U.S. LLC seeks an Assistant Director Product Quality Safety Consumer Health to work in Whippany, NJ, to facilitate and lead routine Pharmacovigilance/QA partnership group meetings and actively ensure process compliance.
The primary responsibilities of this role, Assistant Director, Product Quality Safety Consumer Health, are to:
Who you are
- providing expert direction and driving process optimization, case handling and other related matters for all CH products;
- preparing and delivering presentation proposals to stakeholders, including recommendations for process modifications, trainings, and optimization;
- quality-safety assessment of Product Technical Complaints (PTCs), including counterfeits, of all consumer health drug, nutritional, medical device and drug-device combination marketed products, and clinical trials supply with regard to potential risk to patient health.
Your success will be driven by your demonstration of our LIFE values. More specifically related to this position, Bayer seeks an incumbent who possesses the following:
- master's degree (or foreign equivalent degree) in Pharmacy, Life Sciences, Biotechnology, or a related field plus four (4) years of experience in a related position in the pharmaceutical industry or a bachelor's degree (or foreign equivalent degree) in Pharmacy, Life Sciences, Biotechnology, or a related field plus eight (8) years of experience in a related position in the pharmaceutical industry.
- Two (2) years of the required experience must include working with global Pharmacovigilance regulations and guidelines
- medical concepts represented in product labeling, safety section of the Investigational Brochure, Pharmacovigilance and ever-changing FDA reporting regulations;
- MedDRA coding convention;
- working with databases ARGUS and BRAIN;
- running retrieval queries using data analysis and reporting tools;
- managing competing priorities and timelines;
- participating in and managing cross-functional teams; and
- coordinating and leading projects for multiple Therapeutic Areas.
Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Bayer is an Equal Opportunity Employer/Disabled/Veterans
Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Country:
United States Location: