Senior Pharmacovigilance Associate/ Team Leader (UK, Surrey)

Recruiter
Novella Clinical Resourcing
Location
Surrey
Posted
02 Dec 2017
Closes
05 Jan 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Requirements:

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.

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