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Job Details

PV Licensing Manager (Temporary, 12 months)

Company: Roche
Location:
Reference: 3589885041
Closing Date: 25 Mar 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

The PV Licensing (PVL) Manager is responsible for writing and implementing Safety Agreements for any commercial arrangement between Roche and its partners as appropriate, via PVL templates, per guidance’s and standard operating procedures. The PVL Manager will ensure due diligence activities, decide upon the strategy for the Pharmacovigilance Agreement (PVA), draft, negotiate and implement the appropriate PVAs and provide guidance and tools (e.g. ...

Requirements:

The PV Licensing (PVL) Manager is responsible for writing and implementing Safety Agreements for any commercial arrangement between Roche and its partners as appropriate, via PVL templates, per guidance’s and standard operating procedures.
The PVL Manager will ensure due diligence activities, decide upon the strategy for the Pharmacovigilance Agreement (PVA), draft, negotiate and implement the appropriate PVAs and provide guidance and tools (e.g. Safety Agreement templates) to the responsible Roche functions. The PVL Manager will steer and contribute to business process improvement initiatives and provide support to peers in day to day activities. The PVL Manager will support Affiliates in local safety agreements and provide guidance, and training, to address any queries and manage tools to oversee appropriate management and implementation of local PVAs.

 

Primary Responsibilities and Accountabilities
• Independently draft, negotiate and implement new agreements, as well as, amendments to existing agreements, as per PVL PVA management guidance.
• Evaluate impact of changes in internal processes on PVA templates / agreements / guidance and update accordingly within established timeframes for compliance.
• Support the Head of PVL in managing the oversight of License Partner activities
• Serve as a resource for PDS and other relevant Roche functions to ensure understanding of and compliance with Safety Agreements.
• Support the PVL team and Global Head of PV Licensing in ensuring all PVL guidance documents / work instructions and standard operating procedures are current and up-to-date
• Assist in Pharmacovigilance audits and inspections

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

We are looking for a professional with Bachelor's Degree in life science / health care degree (or equivalent through experience) with proven experience of 4 years in PV Licensing activities in the pharmaceutical or related industry and understanding of Pharmacovigilance regulations and guidelines.  Experience includes either time working in a safety function and/or significant exposure to Pharmacovigilance activities. You will bring:


• Proven excellent written and verbal communication skills with an international or cross functional perspective, able to represent Roche internally and externally
• Understanding of the drug development process and regulatory requirements and their impact on safety licensing activities
• Excellent negotiation skills
• Demonstrable abilities to work with less guidance and supervision in strategising, designing and overseeing assigned activities as well as ad hoc assignments or projects
• Excellent 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-oriented manner
• Demonstrated interest and abilities in training and developing other team members
• Fluent written and verbal English (proficiency in additional languages is a plus)
Travel Requirements: 

Ability to travel internationally as needed

 

If you are proud of contributing and feel you have the commitment to teamwork and innovation that we are seeking, then Roche is the organisation for you.  In return we offer a competitive salary plus the excellent benefits you would expect from a blue-chip organisation, including a genuine interest in your development and progression.
 
To be considered for this position, please apply using the link below.
 
When completing your application, please ensure you attach an up to date CV and details of your current remuneration package.

Who we are

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Apply for this job: PV Licensing Manager (Temporary, 12 months)

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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