Director, Therapeutic Area Lead, Pharmacovigilance, Evaluation, and Reporting(PVER)
Location:
Raritan , New Jersey
Posted:
February 08, 2017
Reference:
000018PZ/3-en-us

Janssen Research & Development, LLC, a Johnson & Johnson Company, is currently recruiting for a Director, Therapeutic Area Lead, Pharmacovigilance, Evaluation, and Reporting(PVER) to be located in Horsham, PA, Raritan, NJ , or High Wycombe, UK supporting one or more of these therapeutic area (TA) /disease state areas:  Immunology, Cardiovascular and Metabolism, Oncology, Infectious Disease and Vaccines, Neuroscience, and Established Products, within the Pharmacovigilance, Evaluation, and Reporting (PVER) department.

 

Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.


Janssen Pharmaceuticals, Inc., a pharmaceutical company of Johnson & Johnson, provides medicines for an array of health concerns in several therapeutic areas, including: attention deficit hyperactivity disorder (ADHD), cardiovascular disease, general medicine (acid reflux disease, infectious diseases), mental health (bipolar I disorder, schizophrenia), neurologics (Alzheimer’s disease, epilepsy, migraine prevention and treatment), pain management, and women’s health. Our ultimate goal is to help people live healthy lives. We have produced and marketed many first-in-class prescription medications and are poised to serve the broad needs of the healthcare market – from patients to practitioners, from clinics to hospitals. For more about Janssen Pharmaceuticals, Inc., one of the Pharmaceutical Companies of Johnson & Johnson, visithttp://www.janssenpharmaceuticalsinc.com/


Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
 
 The Director will manage a group of Scientists, within 1 or more Therapeutic Areas, who are responsible for Post-Marketing Aggregate Safety Reports and to support Safety Management Teams (SMT). The incumbent will oversee compliance, quality, procedures, regulations, timeliness, and consistency of all deliverables which include; Scheduled Reports, Ad Hoc Reports and SMT support.  Scheduled reports include PBRERs/PSURs, PADERs, Addendums to Clinical Overview, and PBRER/PSUR Addendum Reports. Non-scheduled reports include Ad hoc reports in response to health authority queries or internal requests, health hazard evaluations, and labeling support documents.

 

This is accomplished through: Employee recruitment, development and evaluation; cross-functional communication; and application of in-depth regulatory/safety knowledge; Partnering with the Therapeutic Area Safety Head (TASH) on assigned TAs to manage the strategic messaging and safety profile of our products provided in all deliverables; leading complex projects; Insuring accurate and timely analyses and assessments of safety data for all deliverables.

 
Principal Responsibilities will include:
  • Managing (directing, training, motivating, evaluating) the scientific personnel in the assigned TAs to produce deliverables in compliance with regulations and policies
  • Providing leadership and direction to assigned TAs while assuring that all company procedures and global regulations for quality and timeliness are met
  • Guiding employees to use more effective program methodologies and grow in technological, scientific, and procedural efficiency
  • Managing resource needs and resource allocation based on workload to ensure appropriate compliance with report submissions
  • Growing and developing resources; Identifying key talent in the Group.
 
Additional responsibilities include:
  • Establishing credibility and working partnership with the TASH on assigned TAs to ensure that PVER voice is heard in interactions with Medical Safety Officers
  • Daily management of staff activities and responsibility for compliance with SOPs, global regulations/guidelines and corporate policies
  • Building and managing interrelationships with international and domestic regulatory groups as well as Local Safety Officers regarding the timely preparation and submission of deliverables to health authorities.
 
The Primary decision making responsibility centers around:
  • Applying a thorough understanding of international Pharmacovigilance regulations, GMS SOPs and policies, procedures and risk-based decision making.
  • The Director will function at a high level of independence and must be prepared to represent the function and make decisions about the appropriate course of action to take when confronted with specific issues
  • Understand stakeholder/customer needs, be able to network
  • Build alliances; Influence other groups
  •  Interact with Safety, Regulatory and Clinical stakeholder/ partners
  • Uphold J&J Credo
  • Take a leadership role in implementing process improvements to enhance the team’s productivity
  • This is an employee management position.


Qualifications
  • Bachelor’s Degree in Health or Biomedical Science with 13 + years of scientific experience in Pharmacovigilance, Clinical or Regulatory OR an MS/PharmD/PhD/MD and 9 + years of scientific experience in Pharmacovigilance, Clinical or Regulatory is required.
  • Pharmacovigilance experience is preferred.
  • Working understanding of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements is required
  •  Good collaborative and communication skills with scientific subject matter is required
  • Attention to detail along with strong scientific, analytical and conceptual skills is required
  • The ability to understand complex medical-scientific data from a broad range of disciplines is required
  • An understanding of aspects and methods for data analysis, interpretation and presentation is required
  • Prior people management experience is required
  • Strong working skills in MS Word, Excel, PowerPoint and statistics.
  • Travel up to 10% both domestic and international will be required. 


Primary Location
United States-Pennsylvania-Horsham
Other Locations
Europe/Middle East/Africa-United Kingdom-England-High Wycombe, North America-United States-New Jersey-Raritan
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Drug & Product Safety Science

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

Know someone who would be interested in this job? Share it with your network.