Manager, Pharmacovigilance
Galderma Laboratories


Job Info


Company Overview
The Proactiv Company is a leader focused on the global consumer acne market. The Proactiv Company is a joint venture between Galderma, the world's largest independent global dermatology company and Guthy-Renker LLC, a leading direct marketing company.

It unites Galderma's science-based innovation and expertise in dermatology with Guthy-Renker's consumer insights and digital expertise under the Proactiv brand, the world's leading non-prescription acne brand.

For more information, please visit www.proactiv.com

Job Description
The Pharmacovigilance Manager is responsible for managing day-to-day PV activities including adverse event records and medical evaluations. This position will manage the quality and compliance of all PV deliverables and be involved in training the pharmacovigilance specialists, business development, audits/inspections, client relationship management and line management. The PV Manager will lead the safety and benefit-risk evaluations for assigned products and author reports. The PV Manager will be the lead liaison in all Health Canada, FDA and/or any other government body health inspection. This role is responsible for handling adverse event accountabilities in order to comply with local and international regulations, guidelines and applicable directives.

Job Responsibilities

  • 60% - Leads the evaluation of incoming communication for potential adverse event reports via local intake system, phone, fax, mail, social media and other methods in the Wilke database.
    • Medically evaluates and processes adverse event reports daily from the Wilke database for possibility of seriousness and ensures expedited reporting to FDA and Health Canada. If case is serious that case is reported to the proper regulatory authority within the required reporting period.
    • Manages processing of daily queries from Alchemee processing team and ensures response within the same business day.
    • Review literature cases by PV specialists and maintains literature report spreadsheet.
    • Ensures pharmacovigilance aspects of projects are managed in line with budgets and agreed timelines to achieve client satisfaction.
    • Manages signal detection and evaluation activities in accordance with SOPs and guidelines for assigned programs.
    • Generates and manages line listing reports.
    • Participates in and supports annual and other PV internal audits and external inspections.
    • Ensures receipt of adverse events from Marketing programs.
    • Performs and monitors trending for adverse event reporting by leading preparation of quarterly reports.
    • Leads preparation of Annual Summary report for drug products marketed in Canada.
    • Leads reconciliations for Product Quality complaints and reports involving partners.
    • Conducts monthly Health Canada Adverse event search in the Vigilance database.
  • 25% - Provides training to new employees about adverse event collection and reporting including training to call center vendor.
    • Leads weekly and sometimes daily calls/emails with the call center to provide feedback on case processing corrective actions to be taken.
    • Provides training to PV Specialists on all PV related processes.
  • 15% - Ensures the PV team maintains a working knowledge of:
    • Company policies and procedures, departmental processes and associated work instructions.
    • Evolving local and international regulations, guidelines and applicable directives.
    • Alchemee products.
    • Maintains knowledge of skin anatomy and skin diseases.
    • Updates of SOP's and work instructions as needed.
  • Other duties as assigned.


Minimum Requirements
  • Bachelor of Science Degree in Nursing, science discipline, or applicable healthcare education/certifications (i.e. RN, pharmacist) is required.
  • Seven (7) or more years of pharmacovigilance compliance experience in a pharmaceutical company or clinical trials is required.
  • Managerial / functional management or lead experience preferred.
  • Demonstrated knowledge of FDA and Health Canada guidelines for post-marketing drug and medical device safety surveillance.
  • Working knowledge of medical terminology, medical conditions, chemical structures/biological systems and drug products.
  • Familiar with relevant computer software, IT complaint systems.
  • Knowledge of EU regulations as it pertains to PV, preferred.
  • Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
  • Ability to define problems, collect data, perform statistical analysis, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Ability to multi-task under pressure.
  • Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents.
  • Strong leadership and communication skills (oral and written).
  • Proficient with safety coding dictionaries.
  • Proficient in MS Office.


Other Important Information
The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing duties of this job, the employee may or may not be frequently/or occasionally required to:
  • Stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.
  • Climb stairs or ride elevators.
  • Lift and/or move up to 25 pounds.
  • Use close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
  • Manipulate keyboard or otherwise access computer, telephone and hand-held devices.
  • Be exposed to outside weather conditions while going in and out of office buildings.
  • Be exposed to moderate noise level usually in warehouse settings.
  • Be exposed to moving equipment, mechanical parts, and/or high places; or moving between air-conditioned and non-air-conditioned environments.
  • Minimal travel required.

Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.



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