Pharmacovigilance Submissions Specialist

Morristown, NJ, United States
May 31, 2018
Required Education
Masters Degree/MBA
Position Type
Full time
Your tasks and responsibilities

The primary responsibilities of this role, Pharmacovigilance Submissions Specialist, are to:

  • Act as the key decision maker on prioritization of workload; specifically deciding which cases require expedited reporting in order to meet regulatory timelines;
  • Independently analyze case information for reportability based on US labeling, causality, drug code and regulatory approval number and makes submission determination;
  • Perform an accurate US labeling assessment of each adverse event in all cases (NDA, BLA, IND) into the central ARGUS database for all potentially reportable cases;
  • Be familiar with the medical concepts represented in the product labeling of all marketed products, as well as the safety section of the Investigator Brochures for developmental products;
  • Completely understand pharmacovigilance (PV) and the ever-changing Food and Drug Administration (FDA) reporting regulations;
  • Assist with any FDA, company or partner audits related to the submission process;
  • Troubleshoot submission issues;
  • Provide feedback to PV personnel to improve data entry quality and minimize submission errors;
  • Perform Quality Control (QC) check to align with submission standards
  • Collaborate with Assistant Director, US PV Submissions, US Country Life Cycle Managers, and other PV personnel with process improvement initiatives related to expedited reporting.

Who you are

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:

Required Qualifications:

  • Masters degree in Life Sciences plus two years of PV experience; OR
  • Bachelors degree in Life Sciences, Pharmacist, Registered Nurse, or Healthcare Professional (HCP) with four years of PV experience;
  • Ability to work independently;
  • Knowledge of PV processes, PV standard operating procedures (SOPs) and procedures, PV global safety database, Bayer rules regarding case processing, and PV workflow processes;
  • Excellent communication skills, including fluency in the English language;
  • Excellent interpersonal, decision-making and organizational skills;
  • High degree of responsibility and accountability;
  • Collaboration with submission colleagues to maintain consistency in reporting to FDA;
  • Attention to details.

Your application

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: NJ-Morristown