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Pharmacovigilance Agreements & Alliance Management
Clinical Dynamix, Inc.
Job Location: Madison, NJ
Global Pharmaceutical company in Madison, New Jersey is looking for a Pharmacovigilance Agreements & Alliance Management Specialist
We are looking for candidates with a PharmD or RN/NP with individual case safety report processing experience and knowledge of global drug safety/PV regulations, i.e., Drug Safety Associate/Sr. Associate/Manager.

The PV Agreements & Alliance Management (PAAM) Specialist guides and facilitates effective working relationships with Allergan Global Patient Safety & Epidemiology (GPS&E), Companys Business Partners (BPs), as well as strategic departments within the companys affiliates/subsidiaries to foster contract agreements and ensure the smooth, accurate, and timely flow of functions related to onboarding. The PAAM Specialist is versed on Pharmacovigilance Agreements (PVAs)/Safety Data Exchange Agreements (SDEAs) within contractual relationships, and acts as key contact person for internal and external customers, managing these alliances directly and via support staff. Negotiates and maintains Global Pharmacovigilance License Agreements, including the maintenance of compliance. Also, responsible for contributing to new business efforts.

1. Responsible for BP alliance activities. Serve as the liaison between company GPS&E and BP drug safety organizations. Support BP onboarding for new partnerships and maintenance.
2. Manage the onboarding process, establishing PVAs/SDEAs with BPs for new products.
3. Interact with BP for additional information to address questions in establishing a PVA/SDEA, as well as request safety information to support pharmacovigilance efforts.
4. Coordinate the PVA/SDEA review by the safety review team, summarize agreement comments, and participate in the negotiation of the agreement.
5. Contribute to resolving conflicts at team level or higher and facilitate decision making within the team.
6. Assist in educating/serve as a resource to the GPS&E Department.
7. Support in/out-licensing activities.
8. Collaborate with the cross-functional groups that have responsibility of BP activities within company, such as (not limited to) Business Alliance/Development, Clinical Development, Regulatory Affairs, Clinical Operations, Quality Assurance, Legal, and Project Management.
9. Organize and moderate meetings and author minutes/discussion summaries. Solicit items for and set agendas. Send out draft minutes/summaries for comments to both internal GPS&E and BPs, and distribute final summaries to all participants, as well as senior GPS&E staff. Follow up with meeting participants on the resolution of action items from meetings.
10. Maintain and organize internal PAAM files (BP agreements, supporting documents, meeting minutes).
11. Participate in maintaining PV Agreements Database/Portal and Mailbox.
12. Initiate/Develop/Review/Update departmental procedural documents such as SOPs and Training Guidances. Collaborate effectively with authors, reviewers, approvers and trainers.
13. Support audit and inspection activities, as needed.
14. Assist with project management activities.

1. Conduct ad hoc/special projects and analyses for senior management.
2. Participate in major/minor department process improvement initiatives.
3. Escalate issues utilizing governance models and standard communication plans involving BPs.

Education / Experience:
We are looking for candidates with a PharmD or RN/NP with individual case safety report processing experience and knowledge of global drug safety/PV regulations, i.e., Drug Safety Associate/Sr. Associate/Manager.

3-5 years experience in pharmaceutical industry, with at least 2 years in Drug Safety
Experience with global drug safety regulations (i.e., FDA, EMA, MHRA, Bfarm, etc.) and working in a global pharmaceutical drug safety department
Experience working with partners and distributors
Knowledge of GVP, ICSR Reporting, Periodic Safety Reports (PADER, DSUR, PSUR/PBRER)
Project management experience
Experience with process improvement initiatives
Audit/inspection experience preferred
Experience working with and interacting with diverse groups is preferred
Licensure/Credentials: None
Knowledge, Skills, and Abilities:
Advanced knowledge of medical terminology, clinical terms, MedDRA, U. S. Code of Federal Regulations and global regulations regarding AE reporting
Advanced knowledge of drug safety processes, standards, conventions, and governance
Drug safety case processing and reporting knowledge
Proficiency with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook and Adobe Acrobat
Skills in Microsoft Project, Microsoft Visio, Microsoft SharePoint, and WebEx preferred
Must possess excellent skill/ability in the following:
Oral and Written Communication
Planning and Organizing
Decision Making, Judgment, and Problem Solving
People Relationships, Team Building, Motivating Employees, and Influencing Others
Initiative and Accountability
Directing Groups
Promoting Innovation and Process Improvement
Maintaining activities and Coordinating activities
Negotiation skills
Strong analytical skills
Good technical writing and editing capabilities with medical writing expertise
Ability to handle multiple projects at once

How To Apply:
You will be directed to another website for application instructions.
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