PV Manager - Maternity Cover
Sanofi
Reading
4d ago

Pharmacovigilance Manager (Maternity Leave FTC)

Reading, UK

This is a 14-month fixed-term contract position

ABOUT THE OPPORTUNITY

A senior role in the pharmacovigilance department, and an exciting opportunity to manage a multitalented team of PV / safety scientists, while ensuring accurate and timely processing of all individual and aggregate safety information, performing signal surveillance and Risk management activities for small molecules, biologics, vaccines and devices.

The PV Manager will be responsible for ongoing processes improvement, PV compliance, PV training, audit / inspection readiness and the Quality Management systems in accordance with UK / EU PV legislation and Sanofi company procedures.

The responsibilities will also cover the building of effective pharmacovigilance partnerships with other internal stakeholders including the commercial teams.

KEY RESPONSIBILITIES

Patient safety management

  • Lead, manage and develop a team to ensure oversight of accurate and timely processing of pharmacovigilance data as per Sanofi procedures.
  • This includes but is not limited to Individual and aggregate reports, SUSAR management, local signal detection / surveillance, safety exchange agreements, local literature monitoring and local risk management activities.

  • Ensure the effective support of clinical or post authorisation study activities, Patient support programmes, Digital programmes and or Market Research programmes in relation to PV activities.
  • Regulatory Compliance management

  • Ensure that all processes and MCO Pharmacovigilance systems (including training) are in compliance with regulations and global company policies.
  • Effectively support the creation, monitoring, review of the Quality management system within the Pharmacovigilance department.
  • Effectively support the Head of Pharmacovigilance with the management of all assigned PV responsibilities.
  • A representative of Pharmacovigilance department in various internal forums or meetings.
  • Resource management

  • Manage, motivate train, coach and or develop direct reports, according to company policies, and ensure relevant HR procedures are followed.
  • Ensure the continuous professional development of self.

    ABOUT YOU

  • Life science degree or qualified Health Professional (e.g. pharmacy technician, pharmacist, nurse).
  • At least 3 years’ experience within pharmacovigilance or Clinical Drug safety.
  • Previous line management responsibilities would be advantageous.
  • The candidate must have sound leadership and management skills; including excellent cross-functional communication, interpersonal and influencing skills.
  • Ability to demonstrate strategic and business-oriented thinking that is soundly based on an analytical and scientific understanding would be advantageous.
  • We are proud to be a Disability Confident Employer and committed to offering an interview to candidates that request to be considered under the scheme and meet the minimum requirements for the role.

    If you consider yourself to have a disability and would like to ask for adjustments to be made at interview, please email diversity.

    recruitmentUKIE sanofi.com so we can make arrangements for you.

    Pursue Progress. Discover Extraordinary.

    Visas for those who do not already have the right to work in the UK will be considered on a case by case basis according to business needs and resources.

    LI-EUR

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