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Job Details

Senior Pharmacovigilance Associate/Team Leader

Company: Novella Clinical Resourcing
Location:
Reference: 1627212 Snr PV - NCR
Closing Date: 07 Oct 17
Type: Full Time
Salary (£): 40,000 - 60,000
Benefits:

Job Summary:

Novella focuses on providing excellent training and career development opportunities, encouraging growth from within our talented work force. Novella specialises in leveraging technology and Clinical Research and continues to improve the quality and service across a broad range of therapeutic areas including Oncology and Medical Devices.

Requirements:

Novella Clinical is one of the few companies that continues to experience a sustained growth through the recent economic challenges, investing at all levels including infrastructure. We are also proud of being one of the very few global CROs to work to the high standards of ISO accreditation.

We have an exciting opportunity for a Senior Pharmacovigilance Associate/Team Leader, to lead with the delivery of Safety/PVG services according to ICH-GCP guidelines, regulatory requirements and Client SOPs and/or project specific procedures.  

Primary responsibilities include review, preparation and submission of regulatory safety reports (including expedited and periodic) to all applicable Regulatory Authorities, Ethics Committees, Institutional Review Boards (IRBs) and Investigators within defined timelines.  Case end to end experience would be an advantage.

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ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:

 

·         Lead the preparation of safety reports for submission to Sponsors, Regulatory Authorities, Ethics Committees, IRBs and Investigators as applicable.

·         Liaise with relevant internal departments to ensure timely submission of expedited and periodic reports to applicable Regulatory Authorities, Ethics Committees, IRBs and Investigators.

·         Responsible for updating and maintaining Regulatory Submission tracker for assigned projects in collaboration with other internal departments such as Clinical and ISSC.

·         Lead internal and client project team meetings and provides relevant team updates as required.

·         Assists with vendor compliance for third party organizations that perform regulatory safety reporting ·         Delegate the performance ofproject related study close-out and archival tasks.

·         Writing processes and developing documents related to Regulatory Safety reporting, including study-specific processes.

Developing and maintaining tracking reports related to progress of studies, communicating regularly with  the team on status of activities.

·         Manage the collection and maintenance of  Safety Submission Regulatory Intelligence

·         Performs other duties as assigned.including mentoring and training

 

KNOWLEDGE, SKILLS AND ABILITIES:

 

·         Good written and verbal communication skills.

·         Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Regulatory department activities.

·         Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.

·         Ability to work independently, follow instructions/guidelines and demonstrate initiative with oversight.

·         Detailed knowledge of medical terminology, MEDRA coding and use of Argus

·         Good knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.

·         Strong time management skills.

·         Demonstrates professionalism and presents a positive image of the company.

·         Prioritizes time effectively based on project needs. Consistently meets deadlines. Seeks management input with any difficulties in establishing priorities.

·         Identifies personal career development goals and opportunities related to current job. Solicits and applies performance feedback.

·         Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.

·         Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.

·         Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect. Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind.

This is a full time, permanent position which is office based with one of our niche clients based in Surrey

Please apply via https://quintiles.taleo.net/careersection/novella/jobdetail.ftl?job=1627212&lang=en.

 

Keywords, Safety, pharmcovigilance, case reporting, 

Apply for this job: Senior Pharmacovigilance Associate/Team Leader

Contact Information:

Address:  Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
SG1 2ST
England
Tel:  +44(0)1438 221122
Fax:  +44(0)870 762 6257
Website:  Visit Our Web Site

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