Pharmacovigilance Specialist

OBJECTIVE:

Ensures accurate and timely processing of case reports within the department including data entry and coding of local cases and processing world-wide cases for onward review within the department.

Correct and timely reporting to external recipients of single case reports and accurate record keeping of reporting.



ACCOUNTABILITIES:

Triage of incoming case reports

Data entry of case reports into safety database including:

Data entry

MedDRA coding

Drafting initial narratives.

Daily processing of world-wide case reports from the safety database workflow

Expedited reporting of cases to regulatory authorities, ECs and investigators as applicable

Maintaining tracking records for expedited reporting.

Assist in creating and maintaining reporting working instructions for studies/compounds

Contribute to improvement of departmental processes

Any other tasks assigned by manager to assist in departmental activities.
REQUIREMENTS


EDUCATION, EXPERIENCE AND SKILLS:

Required:

Nursing, A level education or international equivalent in scientific/medical field + 1 year experience in medical/healthcare setting or pharmacovigilance or H.S. Diploma + 3 years equivalent scientific/medical/healthcare experience. .

Understanding of medical terminology

Good level of computer literacy with Microsoft applications

Experience and understanding of databases

Accuracy and attention to detail

Good organization skills

Good communication skills

Desired:

Experience or knowledge of pharmaceutical industry

Specific pharmacovigilance knowledge including regulatory requirements

Prior experience with use of coding dictionaries, in particular MedDRA

TRAVEL REQUIREMENTS:

Estimated 0-2 times per year outside the area including possible international travel.

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