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
Competency Statements
- Excellent working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.
- Ethical - Ability to conform to a set of values and accepted standards.
- Accountability - Ability to accept responsibility and account for his/her actions.
- Accuracy - Ability to perform work accurately and thoroughly.
- Analytical Skills - Ability to use thinking and reasoning to solve a problem.
- Detail Oriented - Ability to pay attention to the minute details of a project or task.
- Self-Motivated - Ability to be internally inspired to perform a task to the best of ones ability using his or her own drive or initiative.
- Organized - Possesses the trait of being well organized or following a systematic method of performing a task.
- Technical Aptitude - Ability to comprehend complex technical topics and specialized information.
- Tactful - Ability to show consideration for and maintain good relations with others.
- Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
- Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
- Customer Oriented - Ability to take care of the client needs while following company procedures.
- Communication, Written - Ability to communicate in writing clearly and concisely.
- Communication, Oral - Ability to communicate effectively with others using the spoken word.
- Applied Learning - Ability to participate in needed learning activities in a way that makes the most of the learning experience.
- Working Under Pressure - Ability to complete assigned tasks under stressful situations.
- Demonstrated leadership skills.
- Excellent influencing and negotiation skills.
- Demonstrated ability to work in a matrix environment.
- Ability to lead and motivate a team.
- Ability to establish and maintain effective working relationships with co-workers, managers and clients.
- Fluent in English.
Skills and Abilities
Education: Advanced degree in pharmacy (PharmD preferred), nursing, or relevant, equivalent pharmacovigilance supervisory or management experience.
Experience: Minimum of three years related experience. Demonstrated expertise in pharmacovigilance activities with drugs, devices, vaccines, and biologics preferred.
Computer Skills: Preferred proficiency with Embase, OvidPV, PubMed, Microsoft Office Suite (Outlook, Word, Excel), safety databases, such as Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy, etc.
Other Requirements: Preferred pharmaceutical industry experience including an understanding and working knowledge of global legal, regulatory, and compliance requirements with regards to pharmacovigilance.
Disclaimer
By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. Privacy Policy. Please read this policy carefully for more information on your rights regarding personal data protection.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.
Recruitment Agency Notice:
Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes.
Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy.
Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.
