Overview

Reference Number: JO-2103-464558
Drug Safety Associate
Rate: Negotiable
Job Type: Contract
Location: High Wycombe

Cpl Life Sciences are actively recruiting for a Drug Safety Associate to join an exciting and reputable Pharma company on an initial 10 month contract.

The Drug Safety Associate will have an opportunity to work within an established team. They will be responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.

Key Responsibilities:
Triage of incoming cases to prioritize for daily workflow management
Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval
Preparation Analysis of Similar Events
Perform quality review of Individual Case Safety Reports (ICSR) which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
Liaison with Global Case Receipt and/or Global Medical Safety Operations Physicians (GMSOP) staff as appropriate to clarify appropriate information required for case processing
Other activities relating to case processing as appropriate per case, including but not limited to:
Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol updates for accuracy
Vendor oversight activities for assigned products
Product portfolio subject matter experts

Key Requirements:
Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
Knowledge of pharmacovigilance usually exhibited by 2-4 years experience in pharmaceutical safety-related role

Pharma Experience:
Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Case processing experience is desired
Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
Required skills, abilities and competencies include:
Understanding of medical terminology and ability to summarize medical information
Ability to follow guidelines and procedural documents (experience of working with Standard Operating Procedures (SOPs) etc. preferred)
Oriented to quality, attention to detail and accuracy
Manages own work: ability to prioritize, plan and organize work assignments, and able to work under strict timelines
Ability to work both independently and in collaboration with others
Proactive approach/uses own initiative appropriately
Decision-making and problem-solving skills
Flexibility and adaptability
Positive attitude

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