Accord Healthcare

Senior Manager, PV Safety & Risk Management EMENA

Source: Talent GB

Role Details

The Role

Due to company growth we have an exciting opportunity to offer with this new position within our Scientific Affairs department, we’re looking for a senior SME for Pharmacovigilance Safety & Risk Management to support and be Co-Deputy to the Director of PV Safety & Risk Management EMENA, focussing on products with additional Risk Minimisation Measures (aRMM). You will be responsible for co-ordinating and overseeing all pharmacovigilance activities performed by Accord’s Safety and Risk Management Team members, and ensuring proper support in the qualitative MAH review of PhV aggregate safety reports, signal detection reports or risk management plans delivered by the service provider.

You’ll participate in pharmacovigilance/cross-functional initiatives to develop and implement policies and procedures (aligning with requirements of regulatory authorities, global polices and best practices) relating to the benefit-risk profile of Accord’s products and establish medical and scientific leadership for understanding and responding to the safety and risk profile of Accord products, both in development and on the market. You’ll also assess and approve clinical safety requirements in protocols, safety management plans or contracts for clinical trials or other types of organised data collection systems Accord participates in.

The Person

  • Must be a life-science graduate, pharmacist or physician with a broad and substantial amount of experience in pharmacovigilance.
  • Substantial experience in global pharmaceutical companies, with special reference to preparation of risk management plans and other company core safety documents
  • Thorough understanding of the cross functional drug cycle processes (Clinical, Scientific, Medical and Regulatory affairs) and context applicable to safety surveillance activities.
  • Strategic thinker with excellent problem solving and decision-making skills.
  • Experience within a compliance or corporate governance function at a senior level.
  • Must have proven managerial experience ( decision making and problem solving, people management & budgetary responsibility).
  • Excellent communication, interpersonal and leadership skills.
  • Experienced in people management, a good motivator and be able to coach and mentor personnel.
  • Must reside and operate within the UK or EU.
  • The Rewards

    In return, we offer a competitive salary and rewards package (including increased holiday, annual bonus scheme and a company pension scheme). Not to mention the opportunity to genuinely make a difference in a new and dynamic role within a progressive and expanding business, at an exciting time of growing international reach.

    8 days ago

    London, Null

    Accord Healthcare

    Full-time, permanent

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