W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9wyxjpdhktchjvzmvzc2lvbmfscy9qcgcvymfubmvylwrlzmf1bhqtam9ilmpwzyjdxq

Latest Opportunities

Connecting

PV Manager (Licensing)

Job Title: PV Manager (Licensing)
Contract Type: Contract
Location: Welwyn Garden City, Hertfordshire
Industry:
Salary: Up to £0.00 per day
Reference: BBBH56508_1518021292
Contact Name: Charlotte O'loughlin
Contact Email: c.oloughlin@parity.net
Job Published: February 07, 2018 16:34

Job Description

PV Manager (Licensing)

Contract. 12 Months +. Welwyn Garden City. Pharma

PVL Manager required. 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)

The role

  • 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 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
  • Understanding of the drug development process and regulatory requirements and their impact on safety licensing activities
  • Demonstrated process improvement and change management skills
  • Understanding of FDA, EU Pharmacovigilance Legislation and related regulatory documents, ICH guidelines and national/international GCP requirements

For more information please apply now.

Parity - Source, Develop, Transform

Parity Professionals Ltd acts in the capacity of an Employment Business when providing contract work finding services.

Get similar jobs like these by email

By submitting your details you agree to our T&C's