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Job Details

Pharmacovigilance Licensing Manager

Company: CROMSOURCE
Location: United Kingdom
Reference: HQ00001223
Closing Date: 21 Mar 18
Type: Contract
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

TalentSource Life Sciences is currently searching for an experienced Pharmacovigilance Licensing Manager to work with one of our partner pharmaceutical companies in the South of England.       This is a freelance position with TalentSource for 12 months with the possibility of being extended, on a full time basis. This will be an office based position in the Greater London area and the successful candidate will be working on studies dedicated to one client.

Requirements:

TalentSource Life Sciences is currently searching for an experienced Pharmacovigilance Licensing Manager to work with one of our partner pharmaceutical companies in the South of England.

This is a freelance position with TalentSource for 12 months with the possibility of being extended, on a full time basis. This will be an office based position in the Greater London area and the successful candidate will be working on studies dedicated to one client.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

Key Accountabilities:

The Pharmacovigilance Licensing Manager will be responsible for writing and implementing Safety Agreements for any commercial agreement between the Pharmaceutical Company and its partners as appropriate. In addition, the Pharmacovigilance Licensing Manager will ensure due diligence activities, decide upon the strategy for the Pharmacovigilance Agreement, draft, negotiate and implement the appropriate Pharmacovigilance Agreements and provide guidance and tools (e.g. Safety Agreement templates) to the responsible functions.

Contribute to business process improvement initiates and provide support to peers in day-to-day activities. Support Affiliates in local safety agreements and provide guidance/training, address any queries and manage tools to oversee appropriate management and implementation of local Pharmacovigilance Agreements.

Responsibilities:

· Independently draft, negotiate and implement new agreements as well as amendments to existing agreements, as per management guidance.

· Evaluate impact of changes in internal processes on Pharmacovigilance Agreement templates / agreements / guidance and update accordingly within established timeframes for compliance.

· Support the Head of Pharmacovigilance Licensing in managing the oversight of Licence Partner activities

· Serve as a resource for the department and other relevant functions to ensure understanding of, and compliance with, Safety Agreements.

· Support the Pharmacovigilance Licensing team and Global Head in ensuring all. Pharmacovigilance Licensing guidance documents / work instructions and SOPs are current and up-to-date.

· Assist in Pharmacovigilance audits and inspections.

Education / Qualifications:

· Bachelor's Degree or equivalent in Life Sciences / Health Care related subject, or equivalent (thorough) experience

· Must have significant experience within Pharmacovigilance Licensing activities in a pharmaceutical or related industry.

· A thorough understanding of Pharmacovigilance regulations and guidelines is essential.

· Experience includes either time working in a safety function and/or significant exposure to Pharmacovigilance activities.

Experience, Skills & Knowledge:

· Excellent written and verbal communication skills with an international or cross-functional perspective.

· Understanding of the drug development process, regulatory requirements and their impact on safety licensing activities.

· Excellent negotiation skills

· Demonstrable abilities to work with minimal guidance and supervision in strategizing, designing and overseeing assigned activities as well as ad-hoc assignments or projects

· Proven problem-solving, analytical, impact assessment and strategic thinking skills.

· Strong project and process management skills: proven abilities to effectively and efficiently manage multiple priorities, goals, objectives and tasks through to successful conclusion.

· Demonstrated process improvement and change management skills.

· Understanding of FDA, EU Pharmacovigilance Legislation and related regulatory documents, ICH guidelines and national/international GCP requirements

· Strong interpersonal and partnering skills: has proven abilities to work effectively and efficiently in cross-functional, often virtual and matrix teams.

· Consistently acts in a solution-orientated manner

· Demonstrated interest and abilities in training and developing other team members.

· Fluent written and verbal English

This role many involve some travel

If you have the experience and are interested in discussing the role for this position, please contact Laura Guascone, Laura.Guascone@CROMSOURCE.com.

Why TalentSource Life Sciences/CROMSOURCE?

CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Keywords: Pharmacovigilance, PV Scientist, Pharmacovigilance, PV, Drug Safety, CRO, Outsourced, Contract, Licensing, Pharmacovigilance Manager, PV Manager, Safety Agreements, PVA, Safety Agreement, Temporary, Freelance

Pharmacovigilance Manager

Apply for this job: Pharmacovigilance Licensing Manager

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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