Senior Manager, Clinical Pharmacovigilance (REF9059E)

10 Nov 2024

Vacancy expired!

Job Description

The Senior Manager, Clinical Pharmacovigilance (CPV) is responsible for CPV service delivery including leading and directing activities of the CPV department to ensure services are provided in accordance with company SOPs, department operational procedures and client contracts, safety management plans (SMPs), and work instructions.

Essential Functions Include:

  • Provide direct oversight and direction to CPV Managers, CPV Supervisors, and PV Project Leads, assigned to CPV clients.
  • Coach, mentor, motivate and develop CPV managers, supervisors, and staff.
  • Maintain standards of quality and productivity and adherence to policies and procedures.
  • Make decisions consistent with company guidelines and policies.
  • Foster teamwork and collaboration; resolve conflict.
  • Monitor and provide staff ongoing performance feedback and conduct annual performance and compensation reviews.
  • Participate in staffing responsibilities: hiring, schedules, training, etc.
  • Collaborate with other pharmacovigilance management to coordinate, develop and maintain all aspects of ProPharma Group’s CPV services.
  • Act as client contact and escalation point for case management and process communications.
  • Participate in the development and continuous improvement of processes, workflow, and supporting documents.
  • Participation and support in internal, client, and/or regulatory authority inspections
  • Maintain distinctive quality and commitment as the operating philosophy in carrying out all processes.
  • Continually seek out ways to enhance customer service experience both internally and externally.
  • Communicate needs of the department and provide solutions to management.
  • Perform case review for training feedback.
  • Oversee case management and provide assistance and supervision to staff.
  • Ensure case processing meets SOP requirements.
  • In collaboration with training department, develop and update training documents and training curriculum and identify training needs.
  • Ensure assigned CPV staff is properly trained for assigned duties.
  • Participate in the development and continuous improvement of controlled processes, templates, and other documents, as well as workflow.
  • Support PV Project Leads with client implementation, as needed.
  • Development of data entry, coding, and assessment conventions.
  • Support business development as an SME for proposal development, bid defense presentations, and client.
  • Occasional corporate business travel, approximately 5% of time.
  • Other duties as assigned.

Qualifications

Qualified candidates must have:

  • PharmD, RPh, RN or equivalent.
  • Current healthcare license appropriate for degree or equivalent from state or country.
  • Required: Knowledge of drug development,and U.S.,Canadian, and EUpharmacovigilance regulatory reporting requirements.
  • Required: 4 years of experience working in the pharmaceutical or related industry.
  • Required: 5 years of manager experience that includes supervision of others.
  • Preferred: Significant safety experience, including experience processing SAE reports, generating narratives and queries, working within safety databases, and experience with regulatory submissions.
  • Preferred: Experience interacting with partner or client companies.
  • Preferred: Project management experience.
  • Flexible leadership style and team building skills.
  • Proficient computer knowledge and computer keyboarding skills including proficiency with Microsoft Office Suite (Outlook, Word, Excel).
  • Proficient knowledge of Argus Safety Database operations.
  • Working knowledge and understanding of the legal and regulatory environment within pharmaceutical industry.
  • Excellent organization, prioritization, project management and delegation skills; with strong attention to detail.
  • Self-motivated to maintain high efficiency and productivitylevels, andmanage multiple projects and clients.
  • Excellent project management skills.
  • Strong verbal, written and interpersonal communication skills with clients, external and internal staff.
  • Excellent external and internal customer service skills.
  • Able to work independently and collaboratively in a multidisciplinary team.
  • Able to occasionally work extended and/or flexible schedule to meet client requirements.
  • Excellent attention to detail.
  • Exceptional customer service skills.
  • Strong critical thinking, problem solving and decision-making skills.
  • Flexibility to adapt and meet fluctuating business priorities.

Additional Information

  • All candidates must be legally eligible to work in the United States.
  • We are an equal opportunity employer. M/F/D/V
  • ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.

  • ID: #22534663
  • State: Kansas Overlandpark 66204 Overlandpark USA
  • City: Overlandpark
  • Salary: USD TBD TBD
  • Job type: Full-time
  • Showed: 2021-11-10
  • Deadline: 2022-01-07
  • Category: Et cetera