• Open Position
  • Anywhere
  • Posted 4 weeks ago


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

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 guideline 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.
• Assist Director or Senior Director with daily management of pharmacovigilance professional staff coverage.
• Assist with education of pharmacovigilance or medical information students and fellows as needed.
• Assist team leads with daily functions, training of new hire Professional Staff, and mentoring PV Specialists on team.
• Assist Director or Senior Director in regularly analyzing professional staff productivity in order to make recommendations for training and coverage needs.
• Communicate Company information and pharmacovigilance service changes directly to Med Communications staff.
• Participate in assigned Quality Assurance monitoring.
• Ensure that applicable Quality Assurance SOPs are executed as required.
• 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 Operations Manager might also be called upon to function as a team lead for a client and may be responsible for the following:

• Serve as key contact for communications between the Client and Med Communications team.
• Maintain active role in Quality Assurance process, including case monitoring and monitoring of 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
• Monitor PV Professional Staff coverage to ensure PV service levels are met.
• Identify, initiate, and monitor to completion any resolution actions with regards to complaint management.
• Guide PV Professional 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 Support Staff training.
• Immediately notify Client of any breach in normal function, such as a fire drill or other necessary evacuation or IT issues, which would preclude normal operations.
• Regularly ensure that network files related to Client are up-to-date and readily accessible by team.
• Coordinate with Client in development of curriculums and training plans for new Professional Staff team members.
• Coordinate with Client to schedule meetings and training sessions, and to ensure that all required training requirements are met by all team members.
• 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 client to organize curriculums and training plan sessions for Professional Staff on newly supported investigational and marketed products.
• Coordinate and lead client training or meetings at headquarters.
• Identify and communicate needs for new or updated PV documents/processes.
• Communicate and ensures integration with Medical Information Supervisor for Support Staff activities.
• Communicate and ensure integration of PV activities with key stakeholders for the client.


• Above average attention to detail, teamwork and initiative.
• Ability to interact with other departments within the company and be proficient in e-mail, written, and verbal communication.
• Proficient in Microsoft Excel, Power Point and Word and quickly able to learn new software.
• Demonstrated proficiency in safety systems, such as Oracle Argus Safety and Aris-G.
• Ability to apply regulatory and compliance guidelines to content development.

Competency Statements
• 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 one’s 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.
• Financial Aptitude – Ability to understand and explain economic and accounting information, prepare and manage budgets, and make sound long-term investment decisions.
• 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.

Education: Advanced degree in nursing, pharmacy (PharmD preferred) 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: Prefer proficiency with Embase, Ovid, PubMed, Microsoft Office products, safety databases, such as Oracle Argus Safety and ArisG, and content management systems.
Other Requirements: Prefer pharmaceutical industry experience including an understanding of global legal, regulatory, and compliance requirements with regards to pharmacovigilance.
Physical Requirements

N (Not Applicable) Activity is not applicable to this position.
O (Occasionally) Position requires this activity up to 33% of the time (0 – 2.5+ hrs/day)
F (Frequently) Position requires this activity from 33% – 66% of the time (2.5 – 5.5+ hrs/day)
C (Constantly) Position requires this activity more than 66% of the time (5.5+ hrs/day)

Physical Demand Lift/Carry
Stand F 10 lbs or less F
Walk F 11-20 lbs F
Sit F 21-50 lbs O
Manually Manipulate F 51-100 lbs N
Grasp F Over 100 lbs N
Reach Outward O
Reach Above Shoulder N Push/Pull
Speak C 12 lbs or less F
Climb N 13-25 lbs F
Crawl N 26-40 lbs N
Squat or Kneel O 41-100 lbs N
Bend O

Other Physical Requirements
Vision (Near, Distance)

Telecommuting, or Med Communications, Inc. locations in Memphis, TN, or Geneva Switzerland, or at Client site.

The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee’s ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.


All information gathered is used only for the purpose of employment and none of this information is shared with third parties.

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