POSITION SUMMARY

The Pharmacovigilance Specialist is a professional with scientific, clinical, and therapeutic area expertise responsible for case management activities, expedited/non-expedited reporting activities, periodic reporting activities, risk management, signal detection and surveillance, ad-hoc reporting, and participation in safety meetings for drugs, biologics, devices, vaccines, cosmetics, and/or animal products.

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):

  • Integrate scientific expertise with knowledge of safety database functions to ensure comprehensive case entry and identification of follow-up requirements for cases from multiple sources and for multiple case types, such as spontaneous, clinical trial, post-authorization safety studies, etc.
  • Demonstrate proficiency in the use of the safety database and associated safety system(s).
  • Accurate data entry in the safety database.
  • Demonstrate proficiency with MedDRA and WHO Drug coding.
  • Complete medical literature search activities for pharmacovigilance purposes.
  • Complete social media search activities for Client products for pharmacovigilance purposes.
  • 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.
  • Integrate scientific expertise with knowledge of safety database functions to ensure comprehensive risk management, signal detection and surveillance activities are conducted for the products of responsibility.
  • Integrate scientific expertise with knowledge of safety systems and their functionalities to ensure comprehensive periodic report activities are conducted for the products of responsibility.
  • Integrate scientific expertise with knowledge of safety system and associated safety tool functionalities to ensure comprehensive risk management, signal detection, and surveillance activities are conducted for the products of responsibility.
  • Demonstrate proficiency in the use of content management systems as applicable.
  • Create and review ad-hoc reports from the safety system and associated safety tools.
  • Manage workload for a brand or therapeutic area.
  • Participate in staff training and other measures to ensure Med Communications compliance with Client quality guidelines and key performance metrics.
  • Interact with Pharmacovigilance Physician for scientific information exchange pertaining to pharmacovigilance activities.
  • Supports the role of the QPPV and interacts as required.
  • Completes Quality Review of case data in the safety system.
  • Completes Quality Review of periodic reports and ad-hoc reports.
  • Completes Quality Review of data retrieved from the safety system and associated safety tools.
  • Completes REMS and RMPs activities as per Client specifications, including creation and review of documents supporting REMS and RMPs.
  • Demonstrate ongoing scientific and business expertise relevant to therapeutic areas, including products, disease state management, emerging therapies, and the competitive landscape.
  • Participate in the creation, update and review of pharmacovigilance documents as needed.
  • Comply with all guidelines, policies, legal, regulatory, and compliance requirements.
  • Meet or exceeds service levels and targets for internal and external customers.
  • Mentor new hires or staff changing support areas.
  • Participate in scientific training as appropriate to support assigned Client products.
  • Other pharmacovigilance activities as requested.

 

POSITION QUALIFICATIONS

 

  • 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

  • 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 – Possessing the trait of being organized or following a systematic method of performing a task.
  • Accuracy – Ability to perform work accurately and thoroughly.
  • Technical Aptitude – Ability to comprehend complex technical topics and specialized information.
  • Tactful – Ability to show consideration for and maintain good relations with others.
  • Responsible – Ability to be held accountable or answerable for one’s conduct.
  • 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.
  • Written Communication – Ability to communicate in writing clearly and concisely.
  • Oral Communication – 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.

SKILLS AND ABILITIES

Education: Advanced degree in nursing, pharmacy (PharmD preferred) or relevant, equivalent pharmacovigilance 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

 

Vision (Near, Color)

Hearing

Speaking clearly

 

WORK ENVIRONMENT

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.

Note:

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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