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Pharmacovigilance Associate II

Location Brisbane, California


Job Title:

Pharmacovigilance Associate II

Department / CostCenter:


Reports to (Job Title):

PV Manager

Job Code:


Date Prepared:

June 3, 2015

Full-Time     Part-Time

Regular     Temporary

Exempt     Non-Exempt


State the overall function or purpose of the job.

Participates in activities related to,and processing of Adverse Events for BioMarin post marketed products and investigational products.


List the major responsibilities of the job.

  • Accountable for accurate data capture for individual case safety reports
  • Responsible for narrative creation for individual case safety reports
  • Perform quality review (as appropriate)
  • Ensuring departmental workflow processes and timelines are followed
  • Proactively managing workload to ensure regulatory timelines are met
  • Demonstrated knowledge of safety concepts, global regulatory reporting obligations


Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.

No revenue is generated and there is minimal capital investment (computer and work space, etc.). 


State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.

Bachelor’s degree in Life Science preferred.


State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.

  • Minimum of 1 yearprevious Pharmacovigilance experience required.
  • Strong knowledge of medical terminology.
  • Strong organizational skills, detail oriented, ability to adapt to change
  • Proven team player with the ability to function in a multi-disciplinary environment
  • Demonstrates initiative and accountability
  • Excellent communication skills, both verbal and written
  • Computer literate


Describe the work environment characteristics that an employee encounters while performing the essential functions of the job.

The work environment characteristics 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 the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration.  The noise level in the work environment is usually moderate.

The employee may frequently be required to sit and talk or hear.  The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.  The employee must occasionally lift and/or move up to 25 pounds.  Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.


Describe any equipment required to perform the job.

Computer work, utilizing common software programs and the pharmacovigilance database.


List the key positions, internal and external, with which the job incumbent must interact.

Internal:  Regulatory Operations, Compliance,Clinical Operations

External:  CRO counterparts or appropriate team members at partner companies


List the key accomplishments and skills that must be achieved to be eligible for promotion to the next position, if any, on the career ladder.

To further advance within the Pharmacovigilance team this person must have a good understanding of international regulations surrounding adverse event reporting and the Pharmacovigilance process.

This person will participate in discussions surrounding Risk Management, Signal Detection and have the ability to create hypothesis which could prevent adverse events in the patient population.

The person should be able to provide clear input to department SOPs and work with partners inside and outside BioMarin to ensure all company SOPs are adhered to.

A thorough understanding of regulations pertaining to database systems, their functioning and management is essential.

Excellent writing skills are needed

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