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Drug Safety Specialist - (PV Agreement)

Company:
LanceSoft INC
Location:
Jersey City, New Jersey, United States
Posted:
December 05, 2016
Description:

POSITION SUMMARY:

The PV Agreements & Alliance Management (PAAM) Specialist guides and facilitates effective working relationships with Global Patient Safety & Epidemiology (GPS&E), associated business partners (ABPs), as well as strategic departments within the company’s 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 Safety Data Exchange Agreements (SDEAs)/Pharmacovigilance Agreements (PVAs) 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.

PRIMARY JOB RESPONSIBILITIES:

1. Responsible for ABP alliance activities. Serve as the liaison between GPS&E and ABP drug safety organizations. Support ABP onboarding for new partnerships and maintenance.

2. Manage the onboarding process, establishing SDEAs/PVAs with ABPs for new products.

3. Interact with ABP for additional information to address questions in establishing SDEA/PVA, as well as request safety information to support pharmacovigilance efforts.

4. Coordinate the SDEA/PVA 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 ABP activities, 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 ABPs, 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 (ABP 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.

ADDITIONAL JOB RESPONSIBILITIES:

1. Conduct ad hoc/special projects and analyses for senior Patient Safety management.

2. Participate in major/minor department process improvement initiatives.

3. Escalate issues utilizing governance models and standard communication plans involving ABPs.

POSITION QUALIFICATIONS:

Education:

Healthcare professional with a BA/BS degree in Pharmacy or Nursing

MA/MS or PharmD degree in Pharmacy or Nursing is preferred

Experience:

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