Senior Pharmacovigilance Specialist

OBJECTIVE:

Ensures effective and accurate collection, databasing, reviewing and reporting of safety data.

Assisting in signal generation and safety analysis activities.Responsible for operational pharmacovigilance activities for assigned developmental and/or marketed products.



ACCOUNTABILITIES:

QC review and follow-up assessment of local safety case reports

QC of expedited reporting submission documents for case reports.

Ensure quality of case processing/reporting by providing feedback to Case Processing group

Review of local/world-wide case reports to determine regional reportability.

Liase with CROs and other relevant functional areas within TGRD to obtain safety data, provide safety input or investigator meeting training.

Represent pharmacovigilance department in cross-functional teams or committees that have global study or program impact.

Working knowledge and understanding of designated products/studies

Project support activities for designated developmental products

Create/maintain study summary documents

Reconciliation of clinical and safety databases

Coding review of data from clinical study databases

Unblinding of individual study subjects and maintaining confidentiality

Create study specific pharmacovigilance agreements with CROs

Assist with narrative writing for periodic/ad hoc submissions

Assist with ad hoc or routine safety monitoring activitiesPerform similar events searches (US only)

Project support activities for designated marketed products

Assist with narrative writing for periodic/ad hoc submissions

Assist with ad hoc or routine safety monitoring activities

Review of literature articles to identify safety case reports

Liaise with Healthcare professionals and consumers for follow up of case reports (US only)

Review of product complaints to identify adverse events and follow-up as necessary (US only)

Contribute to improvement of departmental processes
REQUIREMENTS


EDUCATION, EXPERIENCE AND SKILLS:

Required:

Registered nurse or degree level qualification (e.g. Bachelors degree) in scientific/medical field.

Minimum 2 years experience in pharmacovigilance

Experience with safety databases including simple searches & coding dictionaries (MedDRA)

Knowledge of clinical trial methodology and pharmacovigilance regulations

Ability to review, analyze, interpret and present data

Good level of computer literacy with Microsoft applications

Accuracy and attention to detail

Good organization skills and ability to prioritize

Good communication and writing skills

TRAVEL REQUIREMENTS:

Estimated 1-4 times per year outside the area including possible international travel.

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We are an equal opportunity employer.

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