Top GLOBAL Pharmaceutical company with US Headquarters in various NJ locations is looking to expand again: Located in Parsippany, NJ. We need someone who has good clinical knowledge who understands potential medical challenges of drugs and devices. They need pharmacovigiliance experience. They will need to be able to prioritize backlogs. They will oversee 10-12 people. They must have management expeirence. It is a challenging job. Travel is less than 10%. Local only (no relo) salary 120-145k STI is 22.5%; LTI is 10%. May be point of contact for health authority inspections and audits with regards to certain operational policies and procedures.Attend meetings, conferences and forums in order to keep current with industry trends on systems and technology and using this knowledge to influence decision making and enhancements to Bayer pharmacovigilance systems and processes.Serve as the point of escalation for any compliance failure related to Intake or follow-up and implement corrective and preventive actions (CAPA) to ensure future compliance.Responsible for the management of the Drug Safety Response Center members and workflow, including but not limited to:Monitor both the Central and LAM work lists for follow-up action item requests.Create the appropriate type of follow up (HCP letter, consumer letter, Clinical Trial letter etc) and assign to the appropriate individual for processing.Schedule re-evaluation of follow up requests to determine if required number of attempts have been fulfilled, according to Bayer policies and procedures. Generate calls and emails to consumers, healthcare providers, investigators and our licensed partners in order to obtain follow-up Adverse Event information. Create and email Clinical Trial letters to the study sites to request follow up information on study participants.Monitor the Drug Safety Response Center mailbox for incoming requests and inquiries and initiate the appropriate process for obtaining follow up information from HCPs, investigators and consumers.Communicate and collaborate with Global and Local colleagues related to safety issues, clarification of requests and encourages open communication to achieve mutual understanding of issues and resolutions.Work cooperatively toward the identification of areas needing improvements, make valuable suggestions for improvement and develop continuous improvement methods in order to increase proficiency, accuracy and improve overall compliance within the department.Responsible for the management of the Intake Group members and workflow, including but not limited to:Responsible for cross training of the Intake GroupMaintain compliance for source documents received in accordance with FDA RegulationsIdentify and resolve issues within the Intake GroupSupport the creation and maintenance of Operating Instructions (OI) and/or Standard Operating Procedures (SOP) for Intake Group.Monitor and maintain GPV_US mailbox.Monitor Right Fax Utility daily and upload accordingly within Documentum -Management of source documents going to the file roomCollaborate with the Drug Safety Response Center regarding follow-up lettersEnsure all reconciliations for Right Fax, IRMS, and LASH are completed in a timely mannerEnsure all follow-up letters are completed and mailed dailyCollaborate with Medical Communication (and/or other partners) on the identification and resolution of issues. Masters degree in business or life sciences and at least 5 years experience in Pharmacovigilance or Clinical Development or Pharm D, PhD with 4 years of experience in Pharmacovigilance/Drug Safety or MS, BS RPH, RNBachelors degree in business or life sciences and and at least 6 years of experience in Pharmacovigilance/ or Clinical Development/Drug Safety. 2 years or more of management experience.o Demonstrated ability to solve complex problems independently.Deep understanding of Global Regulatory (ICH/FDA/EMEA) guidelines.Deep knowledge of Global PV functions & processes, with ability to interpret, document and improve.Expert usage and understanding of medical terminology is essential.Accomplished and very good/expert knowledge in MedDRA coding using terminology prescribed by global regulatory authorities is crucial.Very good knowledge of compliance relevant regulatory obligations regarding pharmacovigilance, specifically reporting rules and timelines. Analytic, systematic and strategic thinking. Proven ability to work in international teams with members from different cultural backgrounds.Excellent negotiation, presentation and communication skills.The aptitude to organize, analyze and summarize information and communicate results is required.The ability to develop cooperative working relationships with all levels of staff is crucial, including external partners.Ability to influence without authority. Associated topics: clinical trial, director, drug safety, formulation design, formulation development, head of the laboratory, leader, principal investigator, research group leader, scientific director
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.