Pharmacovigilance Case Management Lead Jobs

Ensure that the continuation of services, case management and reunification services will be provided 7 days a week.

Must be computer literate with working knowledge of Microsoft Windows (Word Perfect, Microsoft Word, Excel)

Monitor compliance and implementation of program services.

Ensure ORR safe and timely release policy revisions are appropriately implemented within required timeframes.

Serve as primary liaison between ORR, DHS, Border Patrol, legal services and Immigration Court.

Communicate all placement referrals with Lead Clinician and remain on call.

DESIRABLE QUALIFICATION CRITERIA: In addition to the mandatory qualifications, experience in the following is desired:

For more information on the array of benefits programs, please visit https://www.nga.mil/careers/Benefits_&_Pay.html.

Pay Band, Salary Range - Ext

Band 04 $112,015 - $172,075

PERMANENT CHANGE IN STATION: PCS expenses are not authorized.

Know the World, Show the Way ... from Seabed to Space

Bachelor's degree and 2 years of directly related experience OR Associate's degree and 6 years of directly related experience

Conduct follow up activities with HCP and patients.

Complete assigned reports and provide support for vendor related queries relating to ICSR processing.

Position Title – Pharmacovigilance Specialist

Contract Length – 6 months

Ensure the drafting / revision of all quality documents inherent in the vigilance responsibilities,

Implement a routine PV system meeting all FDA and HHCHC HC requirements,

Promote, maintain, and improve compliance with pharmacovigilance regulatory requirements,

Implement systems to measure compliance with agency regulatory requirements ,

Adequate theoretical and practical knowledge for the performance of pharmacovigilance activities,

Carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports,

Required Project Management Professional (PMP) or Certified Scrum Master (CSM) certification

Establish a project management plan to summarize the scope of work, deliverables list, master schedule, org chart, quality expectations, etc.

Apply best-in-class project management approaches to support execution.

Track and facilitate the resolution of project risk, issues and manage escalations to the PMO and GPS leadership.

Support program/project managers with project coordination (scheduling meetings, taking minutes, documenting risks/mitigations).

3+ years of biotech/pharmaceutical experience supporting/managing pharmacovigilance related projects is preferred.

Vendor Management Oversight for pharmacovigilance experience

Previous experience with adverse event reporting systems, FDA and EU drug safety/Pharmacovigilance requirements

Oversee and manage project and steer in the right direction

8+ years of biotech/pharmaceutical experience in Drug Safety/Pharmacovigilance

Experienced in drug safety for a small biotechnology corporation strongly preferred

Experienced with running safety review board / steering committee meetings

Equivalent combination of education and experience.

Demonstrates strong time-management and organizational ability to creatively analyze and improve processes and consistently produce high quality work.

Understand and interpret regulatory agency policies and guidance as it pertains to GVP requirements.

PhD in related discipline and a minimum of eight years of related experience; or,

Proven technical understanding and application of regulatory agency policies and guidance pertaining to GVP requirements.

Possesses strong written and oral communication skills, with demonstrated ability to translate complex concepts across all levels of the organization.

1 or More Years of PV experience and knowledge of FDA regulations required

Education Qualifications (from an accredited college or university)

Bachelor's Degree in nursing, pharmacy, or healthcare related field preferred

Ensure NIH Clinical Center Pharmacy’s policy and procedures are incompliance with requirements by local regulation and the Sponsor.

Interact with IDCU/IVAU managers and Pharmacy QC/QA team.

Eight (8) years of experience in a science related field.

Demonstrates expert knowledge working in the research laboratory environment.

This is a long-term contract position which offers:

- Competitive compensation and comprehensive benefit package

Expert knowledge and proven track record of REMS management and operations

Recent Pharmaceutical industry experience with patient services and/or vendor management

Oversight and management of Risk Evaluation and Mitigation Strategies (REMS) day-to-day activities

Liaise with specialty pharmacies to ensure that all REMS requirements and processes are managed and maintained

Manage day-to-day activities of Risk Evaluation and Mitigation Strategies (REMS) program to maintain regulatory compliance

Assess and implement ongoing REMS process and service-related improvements to ensure continuity and patient satisfaction while fostering a positive prescriber experience

If you are energized by leading teams of people through change.

If you are motivated by measured outcomes.

Identify trends in associate behavior and performance to guide coaching, training, and communication; assist in identification of process improvements.

Share and encourage best practices for motivating Care Navigators; foster a collaborative team environment; foster a culture of innovation.

Communicate regularly with the team regarding policy changes, improvement opportunities, and policies.

This job requires you live within 90 miles of the East Hanover site of Novartis.

Perform other duties as assigned by management and/or business partners.

Strong knowledge and experience using computer programs and pharmacovigilance software such as ArisG, Oracle Argus or PV-Works.

Pay Range: Variable based on experience and education.

Participate in all required training and continuing education sessions.

Complete other responsibilities and activities as assigned by supervisor and/or SCI partners.

Provide initial and ongoing staff training for call center staff and coordinate content efforts and responsibilities with PV staff.

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

Pharm D or HCP or Equivalent with at least 8 years’ experience in PV case management activities

Leadership, Teamwork and Management skills;

Pharmacovigilance with significant involvement in case management

Successfully managed case management teams

To generate user requirements for technology enhancements for inbound processing and lead the implementation from a business perspective