PV/SDEA - Safety Alliance Manager (REMOTE OR OFFICE BASED) - Berkshire, UK

Reference: RS181220A

Expiry Date: 18-03-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Maidenhead
Windsor and Maidenhead
United Kingdom

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Job Description

PV/SDEA - Safety Alliance Manager (REMOTE OR OFFICE BASED) - Berkshire

To strengthen my Clients Patient Safety Team, we are looking for a talented individual to fill the position of: PV/SDEA - Safety Alliance Manager.

As a PV/SDEA - Safety Alliance Manager, you will collaborate with internal stakeholders and external business partners in the end-to-end lifecycle management of Safety Data Exchange Agreements (SDEA) / Pharmacovigilance Agreements (PVA):

  • Lead the preparation, negotiation and conclusion of SDEAs/ PVAs relating to Development and Commercial partnerships.
  • Support the establishment and maintenance of SDEA/ PVA related business processes, standards and systems.
  • Act as a key contact point on all matters relating to SDEAs/ PVAs with internal stakeholders (e.g. Safety, Quality, Regulatory, Business Development, Alliance Managers, Supply, Commercial, Legal, Affiliates) as well as external business partners.
  • Ensure oversight on all assigned SDEAs/ PVAs, contractual obligations and associated deliverables throughout the lifecycle of the partnership.
  • Ensure compliance with company guidelines, legal and regulatory requirements and industry practice.
  • Actively support audits and inspections as well as resolution of CAPAs.

About You

You should have:

  • Bachelor's degree is required, Master’s degree is preferred.
  • At least 3 years’ experience in pharmacovigilance, regulatory, quality, legal, contract management and/ or compliance related role.
  • Good working knowledge of global clinical and pharmacovigilance regulations and guidelines. General understanding of the functional requirements for all critical pharmacovigilance processes.
  • Good understanding of contractual concepts and terminology. Experience drafting, interpreting and managing agreements with business partners is preferred.
  • Strong critical thinking/ analytical skills and attention to detail.
  • Good negotiation and problem-solving skills.
  • Effective time management skills and ability to adapt to changing priorities.
  • Excellent oral and written communication skills - Proficient in English.
  • Strong team orientation, experience and ability to work in a cross-functional and cross-cultural environment.
  • Self-starter and ability to work autonomously.

** CAN BE REMOTE OR OFFICE BASED **

To Apply!

To apply for this role, please contact me, the Clinical & Medical Hiring Lead, asking for Roland Schnapka, on +44 (0)207 801 3387 or send a full CV to roland@advtalent.com. Alternatively, please press the red “Apply for position” button and follow the registration process.

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