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

Reference: RS181220A

Expiry Date: 18-12-2021

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

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.


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.

We provide a high level of service because we believe this matters. Our people place individuals at the Specialist, Expert, Regional and Global Head levels, so if you want some advice on when or how to make your next step, or to understand what that next step might look like, let’s collaborate and explore these ideas with each other. ADV Talent Partners only advertise around 30% of our active roles, so for us to really help you, please Register or call us. We provide permanent and contract roles in the following areas, across the USA, Europe and Asia Pacific. General switchboard number +44 (0)207 801 3380.

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