Pharmacovigilance Manager

Position Summary

The Pharmacovigilance Manager is a managing professional with scientific, clinical, and therapeutic area expertise who is responsible for implementation of pharmacovigilance services for Med Communications PV clients.

Essential Functions

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.

Essential Functions Statement(s):

• Capability to perform activities of the PV Specialist and Sr. PV Specialist for case processing, literature processing, periodic report activities, and risk management activities.
• Demonstrate proficiency in the use of the safety database and associated safety system(s).
• Thoroughly and accurately document cases in the safety database, consistent with Client operational procedures, to ensure comprehensive case processing.
• Knowledge of regulatory and compliance guidelines to ensure expedited and non-expedited submissions to the appropriate entities.
• Knowledge of regulatory and compliance guidelines to ensure periodic report submission to the appropriate entities.
• Knowledge of regulatory and compliance guidelines to ensure risk management activities are completed and reported within regulatory determined timelines to the appropriate entities.
• Interact with Pharmacovigilance Physician for scientific information exchange pertaining to pharmacovigilance activities.
• Supports the role of the QPPV and interacts as required.
• Regularly attend product training sessions to maintain awareness of and knowledge of relevant updates.
• Supervise assigned professional staff including completion of performance evaluations and periodic reviews.
• Assist Global Head of PV or PV Project Leads/Team Leads with daily management of PV staff coverage.
• Assist with education of pharmacovigilance or medical information students and fellows as needed.
• Assist Project/Team Leads with daily functions, training of new hire Professional Staff, and mentoring PV Specialists on team.
• Assist Global Head of PV or PV Project/Team Leads in regularly analyzing PV staff productivity in order to make recommendations for training and coverage needs.
• Communicate Company information and pharmacovigilance service changes to Med Communications staff.
• Participate in assigned Quality Assurance monitoring.
• Ensure that applicable Quality Assurance SOPs are executed as required.
• Create, review, and provide feedback on Work Instructions and Handling Guides or other similar documents.
• Coordinate Client site visits
• Comply with all guidelines, policies, legal, regulatory, and compliance requirements.
• Other pharmacovigilance activities as requested.
• The Pharmacovigilance Team Leader might also be called upon to function as a Project/Team Lead for a client and may be responsible for the following:
• Serve as key contact for communications between the Client and Med Communications PV team.
• Maintain active role in Quality Assurance process, including case monitoring and monitoring of key performance indicators.
• Take action to include staff training, creating or revision of new work instructions, or other measures to ensure Med Communications compliance with Client quality guidelines and key performance metrics.
• Monitor PV Staff coverage to ensure PV service levels are met, according to the contract signed by MC with the PV client.
• Identify, initiate, and monitor the completion of any resolution actions with regards to complaint management.
• Guide PV Staff in follow-up request handling as needed in accordance with Client policies and procedures.
• Coordinate directly with leadership regarding any updated Client operational procedures necessitating PV Staff training.
• Immediately notify Client of any breach in normal execution of activities or issues which would preclude normal operations.
• Regularly ensure that network files related to Client are up-to-date and readily accessible by the team.
• Coordinate the development of training curriculums and training plans for new Professional Staff team members assigned to a client.
• Coordinate with Client to schedule meetings and training sessions, and to ensure that all required training requirements are met by all team members before starting the work.
• Coordinate scheduling of Professional Staff out of office coverage.
• Plan and monitor resource allocation of Professional Staff team members.
• Provide input on hiring of new Professional Staff to Management Team.
• Identify new opportunities for client-related services.
• Coordinate with new clients or new activities added for an existing client to organize training curriculums and training plan sessions for PV Staff on newly supported investigational or marketed products.
• Coordinate and lead client training or meetings.
• Identify and communicate needs for new or updated PV documents/processes to supervisor and PV QAM.
• Communicate and ensure integration with supervisor for Support Staff activities.
• Communicate and ensure integration of PV activities with key stakeholders for the client.

Position Qualifications