Pharmacovigilance (PV) Case Specialist
BAYER - Montville, NJ

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Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women's Healthcare. As a specialty pharmaceuticals company, we focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world's leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear. Case Processing Specialty Medicine 4 We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events.

If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now.

To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
  • The PV Case Specialist reports to the PV Case Leader and is responsible for coding, narrative preparation, data entry and routing of all serious and non-serious adverse events received from physicians, investigators, pharmacists, nurses, consumers, patients, CROs (Clinical Research Organizations), and sales representatives. Additionally, the incumbent will perform manual triage of non-serious cases to ensure the accuracy of that determination with the potential to upgrade to serious for higher level medical review. The incumbent is responsible for preparation, interpretation, and entry of these adverse events into the global database for global distribution. The incumbent will be responsible for assessing information completeness, obtaining and adding required information from local affiliates when necessary. For non-serious cases, the incumbent also will be responsible for closing action items and locking the case and routing to archive or distribution as appropriate. Additionally, the incumbent is responsible for assisting with the training and mentoring of the PV Case Specialists relative to changing policies, procedures, regulations, and global database documentation processes.
The incumbent will:
  • Be responsible for the day-to-day training and mentoring of the PV Case Associates relevant to changing policies, procedures, and global database documentation
  • Promptly and accurately interpret and enter serious and non-serious adverse events into the global database for distribution.
  • Perform assessment of cases regarding the global listedness
  • Create comprehensive narratives procured from relevant, related information from various source documents.
  • Request all pertinent follow up information from local affiliate for the completion of case reports within specific timelines as prescribed by global regulations and SOPs.
  • Accurate coding of incoming serious and non-serious adverse events using MedDRA terminology.
  • Verify, as prescribed by regulatory guidelines, that trade names are correctly translated into INN (International Non-proprietary Name).
  • Independently assess follow-up, lock, and distribute/archive non serious cases.
  • Generate necessary safety reports from global database with minimal supervision.
The selected candidate is required to possess the following:
  • MS degree with 3 years experience (2 years of PV and 1 year relevant clinical experience); or BS, RPH, HCP or Life Science degree, plus 5 years experience (4 years of PV and 1 year of relevant clinical experience); or High School diploma with 8 years experience (7 years of PV and 1 year of relevant clinical experience).
  • Global drug safety database knowledge, along with proficient knowledge of regulatory roles and regulations, locally as well as globally is essential.
  • Exceptional oral and written communication skills are essential.
  • Must possess excellent clinical interpretation skills based on limited information provided along with a comprehensive understanding of medical terminology. Incumbent should possess excellent interpersonal, decision-making, and
organizational skills, along with practiced training skills.
  • Additionally, extensive knowledge of Safety policies and procedures, along with FDA and ICH regulations is beneficial. Understanding the coding techniques of incoming serious and non-serious adverse events using terminology prescribed by global regulatory authorities is beneficial. The ability to develop cooperative working relationships with all levels of staff is critical.
  • Quality traits of diplomacy, professionalism, tact, and arbitration are critical to this position.

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For when you can't "bayer" the pain, Bayer Corporation makes your medicine. The US headquarters of pharmaceuticals and materials...