Surveillance Associate Borders   £31,000 per Annum - £42,000 per Annum

We are currently recruiting for a Surveillance Associate to work in one of the world's largest research based pharmaceutical companies.

The role:
To perform safety surveillance of pharmaceutical products through signal detection and clarification, preparation of periodic and ad-hoc safety reports, effective analysis and communication of safety related questions to internal and external customers, and to promote and advance the field of Global Patient Safety.

Key Responsibilities:

1. Signal Detection/Clarification
Effectively utilize available tools to identify, clarify and communicate potential safety signals from multiple data sources.
Consult and coordinate with safety physicians and other appropriate personnel to ensure thorough evaluation of safety signals.
Effectively communicate relevant safety information to the appropriate persons. Actively participate in therapeutic area and departmental safety meetings.

2. Safety Inquiries
oDefine evaluation plan with partners (physicians, team members, business partners) to appropriately assess and complete responses for inquiries from both regulatory authorities and other internal and external sources regarding product safety.

3. Periodic Reports/ Pharmacovigilance (PV) Plans
Complete the analysis of the safety data related sections and maintain oversight of periodic reports such as Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), European Union (EU) Annual Safety Reports and Ethical Review Board (ERB) Line Listing Reports.
Meet periodic reporting requirements as per the periodic reports calendar.
Prepare and maintain PV plans.
Identify and propose process improvements.

4. Promote and advance the field of Global Patient Safety

Develop expertise in surveillance activities and documents and apply shared learning and influence across the surveillance team.
Ensure quality and compliance is maintained.
Conduct safety surveillance training (external and internal).
Understand the roles and responsibilities of the EU Qualified Person.

Job Requirements:

o Education: Bachelors degree or higher in the healthcare field (with preference given to pharmacy, medical or nursing) or equivalent demonstrated clinical experience
o Experience within Global Patient Safety or demonstrated understanding of Pharmacovigilance and Pharmacoepidemiology
o Clinical knowledge of various disease states, human physiology and pharmacology
o Strong Analytical/Quantitative Skills
o Effective communication skills to interact with diverse groups and individuals
o Demonstrated consistent delivery of high quality on time work products

Other Information:

Preferred Skills:
o Knowledge of global safety regulations
o Ability to manage multiple tasks simultaneously

Salary negotiable

For more information about the company and location please apply online
Req118353/AGY

Job Reference:   Req118353

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