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Job Details

PV Licensing Manager

Company: Roche
Location: Basel Headquarter Welwyn
Reference: 201805-102857
Closing Date: 21 Aug 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

PV Licensing ManagerThe 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:

PV Licensing Manager

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. In this role you will:

  • Independently draft, negotiate and implement new agreements, as well as, amendments to existing agreements

  • 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.

  • Closely collaborate with internal and external contacts with respect to Pharmacovigilance issues related to commercial arrangements

  • Advise the Global Head PV Licensing and the team of any unresolved problems / on-going issues regarding PVAs.  Identify and implement solutions under the leadership of Head of PVL or Senior PVL manager.

  • Represent PVL team on cross functional task forces

  • 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

  • Upon identification of deficiencies in processes impacting License Partners, collaborate with appropriate stakeholders to obtain an impact assessment and ensure appropriate communication with License Partners

  • Ensure accurate and up-to-date information in the contracts and agreements appendix of the Pharmacovigilance System Master File.

  • Support members of PVL to achieve department goals and objectives

  • Mentor / coach / train new members of PVL as appropriate

You bring:

  • Bachelor's Degree in life science / healthcare degree (or equivalent through experience) with proven experience of 4 years in PV Licensing activities

  • Understanding of Pharmacovigilance regulations and guidelines.

  • Proven excellent written and verbal communication skills with an international or cross functional perspective, able to represent Roche internally and externally

  • Excellent command of English

  • Excellent problem-solving, analytical skills.

  • Understanding of the drug development process and regulatory requirements and their impact on safety licensing activities

  • Excellent negotiation skills

  • Ability to collaborate and communicate effectively and efficiently in an international matrix

Get in touch with the Recruiting Team Switzerland +41 61 682 25 50

At Roche, 94,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity

Roche is an equal opportunity employer.

Research & Development, Research & Development > Drug SafetyBasel Headquarter, Welwyn

Apply for this job: PV Licensing Manager

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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