Pharmacovigilance Manager - Morristown, NJ | Biospace
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Pharmacovigilance Manager

Pearl Therapeutics

Location:
Morristown, NJ
Posted Date:
11/15/2016
Position Type:
Full time
Job Code:
43235
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Drug Safety, PharmD,

Job Description

Pearl Therapeutics, a wholly-owned subsidiary of AstraZeneca, is a growing, dynamic company focused on developing inhalation combination therapies for the treatment of highly prevalent chronic respiratory diseases, including chronic obstructive pulmonary disease (COPD) and asthma.  Pearl is seeking to hire individuals that bring energy and passion to deliver the medicines that provide patients and healthcare provider’s therapies to achieve better clinical outcomes.  

Purpose: The Pharmacovigilance Manager is responsible for managing and overseeing the company’s drug safety reporting process. This person will assist in supervising and managing the safety tasks performed by a safety provider and will focus on efficient, accurate and timely reporting of adverse events, adequate management of Adjudication Committees and Data Monitoring Committee. This person will also play an important role representing Drug Safety in interactions with clinical, scientific and regulatory groups at Pearl

Duties and Responsibilities:
•   Lead Pharmacovigilance activities for clinical study startup Globally
•   Lead / Guide Pharmacovigilance Associates for quality control (QC) of individual case safety reports (ICSR) ensuring that cases are reviewed and completed in a timely manner in accordance with appropriate SOPs (standard operating procedures), study protocols and regulatory guidelines
•   Collaborate with other departments to ensure appropriate collection and handling of safety data
•   Leads, manage and mentors the Pharmacovigilance team and Pharmacovigilance vendors
•   Ensures compliance with health authority regulations in all aspects of PV case processing and reporting
•   Tracking compliance of expedited safety reports in relation with Pharmacovigilance vendors
•   Contributes to regulatory responses, Investigator’s Brochure (IBs), Informed Consent forms (ICFs), study protocols, and other documents as required
•   Collaborates with team members on the development and implementation of PV standard operating procedures (SOPs) and working processes (WPDs)
•   Manage / Lead and contribute to aggregate safety reports including Developmental Safety Update Report (DSUR) and other periodic safety line listings as required
•   Manage and Review reconciliation SAE data between clinical and safety databases
•   Assist with data-lock reconciliations and ensure all cases are complete and all outstanding queries are resolved and closed
•   Review of submissions to ensure procedural compliance and to assess the medical safety content for accuracy
•   Liaise with clinical operations, regulatory affairs, clinical research organization (CRO) and data management groups regarding safety data collection and data reconciliation
•   Provides strategic or operational input on project teams and Interact with senior management to report on projects
•   Remains informed of all appropriate current health authority regulations and guidance globally

Requirements

Education/Experience:
•   The Pharmacovigilance Manager is a Nurse (RN/BSN) and/or Pharmacist (RPh/PharmD) with at least 6 years of experience in Pharmacovigilance with a senior role
•   Experience with Global drug safety database is required and MedDRA knowledge utilizing WHO- Drug dictionaries for coding consistency and knowledge of regulatory regulations and guidance
Behaviors/Skills:
•   Ability to independently identify problems and effectively offer solutions
•   Must be team player, detail oriented and be willing to work in a fast-paced environment with time-sensitive materials
•   Must be proficient in using Microsoft Office programs such as Excel, Word and PowerPoint


*Also looking for Sr. PV Associates and PV Associates