10 days ago on roche.com

Safety Science Manager (Core Pharmacovigilance)

Roche AG

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Safety Science Manager (Core Pharmacovigilance)

Safety Science Manager (Core Pharmacovigilance)

Switzerland, Basel-Town, Basel

The Manager of CPV will provide leadership, management, coaching and functional expertise to ensure individuals are able to contribute to the delivery of global clinical studies and functional projects. He/She will ensure effective resource management for the team and department in a given therapeutic area, and provide functional expertise to initiatives and activities across the organization.

Job Responsibilities

  • Lead &/or contribute to the development of functional processes and initiatives across CSSD. Represent department and/or function on PD and cross-functional initiatives and accountable for making decisions that have wide organisational impact.
  • Provide leadership and support for direct reports in order to optimize their capability to successfully contribute to deliverables.
  • Lead by example and create a positive work environment by encouraging mutual respect, innovation and accountability on a functional and project level, both locally and globally.
  • Identify and manage resource needs through proactive planning and effective recruitment.
  • Ensure that direct reports are appropriately trained, developed and coached to comply with company and regulatory standards.
  • Conduct ongoing performance management dialogue and complete the required steps of the performance management cycle, performance calibration, talent management and succession planning.
  • Advocate, drive and support change management within the organization
  • Therapeutic Program Point Person
  • Collaborate with key stakeholders to support/enable effective delivery of assigned deliverables
  • Coaching and guiding teams through effective issue management
  • Ensuring operational resources are correctly allocated and in line with project demand.
  • Responsible for making business driven decisions to support the management of the functional budget.
  • Monitor/promote quality, productivity and efficiency of the team
  • Ensure compliance to company policies and processes.
  • Lead &/or contribute to functional meetings to share knowledge and best practice.
  • Collaborate effectively with internal and external stakeholders
  • Develop and maintain efficient and effective safety strategies to ensure up to date processes and procedures
  • Liaise with and manage development partner relationships  for maximal effectiveness and quality
  • Who you are
    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

    Education, Skills and Experience

    Minimum:  Bachelor’s degree in healthcare related field or equivalent experience and 7 years of relevant experience.  MD, RN, PharmD, PhD preferred.

    • Knowledge of the pharmaceutical industry and experience in drug development, including a comprehensive knowledge of pharmacovigilance activities and requirements
    • Demonstrated ability to lead and influence effectively in a matrix environment.
    • Excellent communication skills. Well versed in utilizing a variety of influencing techniques to quickly build respect and gain the confidence of others.
    • Demonstrated experience of proactively driving a variety of tasks and projects and delegating to a team.
    • Strong written and verbal communication skills to a variety of levels and teams. Demonstrated persuasion and influence skills.
    • Ability to operate objectively and independently as a leader and as a member of a team, as required
    • Ensure collaborative and constructive business relationships with external vendors
    • Ensure that staff communication and employee relations are managed proactively within the site to maximize the wellbeing of the employees.
    • Actively install the values of the company in the teams and their activities at the specific site.
    • Understanding of the MedDRA dictionary and coding
    • Understanding of signal detection planning and process
    • Understanding of PV activities within safety Science (ICSR process, medical review, signal detection …) and experience with key safety deliverables (PBRER, PADER; DSUR, IND updates, DSRs, ICF, SSR…)
    • Understanding labeling documents and their maintenance
    • Establish and implement best practice sharing in pharmacovigilance activities.
    • Strong negotiation skills

  • Who we are
    Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

    Roche is an equal opportunity employer.
  • Job facts
    • Location Switzerland, Basel-Town, Basel
    • Function Development
    • Subfunction Drug Safety
    • Schedule Full-time
    • Job level Team Leader
    • Job type Regular Employee
    • Division Roche Pharmaceuticals
    • Posted since 2017/12/05
    • Job-ID 3415423009
  • Get in touch
    Cristina Varela 41616872527