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Partner Market Pharmacovigilance Manager

Sanofi

We are looking for a Partner Market Pharmacovigilance Manager, based inIstanbul with the following qualifications:

  • Define, set up & implement the business model under the direction of the Multi-Country Safety Head (M-CSH). Set up and ensure an effective oversight and management of the Partner Market Service Providers (PMSP) across the Multi-Country Organization (MCO)/region including regular meetings with the PSMPs, monitoring compliance with the PV Agreements (PVAs) and maintenance of the PVA.
  • Ensure the implementation of PV in assigned territory, acting as the interface between Patient Safety and Pharmacovigilance (PSPV), the MCSH and the PMSPs.
  • Transversal coordination: Set up and ensures PV training, processes and tools are in place with the PMSPs, ensures that they are compliant with PSPV standards and are harmonized across countries. The Partner Market Pharmacovigilance Manager shall identify areas of risk and escalate and work with stakeholders to resolve. Promote and deploy initiatives aimed at harmonizing and promoting best practices across PMSPs. In addition, when appropriate, he/she may need to work collaboratively with the Global PSPV Subject Matter Experts in developing process-related solutions oriented at the PMSPs as well as interacting closely with other PSPV functions to contribute to the appropriate management of the Sanofi Pharmacovigilance system.
  • Is the contact point between PMSPs and the Global teams, and performs other activities which require a coordination role as new process implementation, communication to partners, implementation of additional Risk Minimization Measures and its tracking, contribution to the PSMF, Supports Inspection and Audit activities etc.
  • Work collaboratively with other Sanofi functions contributing to the success of the PMSPs collaboration.
  • May provide support to the Turkey affiliate in activities related to:
  • Ensure that local PV activities relating to assigned responsibilities are performed in compliance with the PSPV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of Sanofi products on the market in the assigned country(ies). Establish and maintain a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures, tools and training.
  • Ensures the appropriate management of PV activities associated to clinical trialsin the MCO, notably notifications to Health Authorities and oversight of any outsourced activities if applicable.

Knowledge and Skills

General

  • Working knowledge of international pharmacovigilance requirements, with experience in their practical application. Compliance focused.
  • Working knowledge of PV Systems, central and local PV operations, PV processes, regulatory compliance, standardization, and Pharmacovigilance Agreements in partnerships.
  • Knowledge on pharmacovigilance tools and procedures.

Competencies

  • Excellent organizational and planning capabilities, and experience in problem-solving
  • Strong negotiation skills
  • Strong interpersonal skills.
  • Team player
  • Fluency in English (both oral and written, including technical terminology) and communication skills (oral/written)
  • Persion language is a plus
  • Inter-cultural skills/ability to work across cultures.
  • Demonstrate problem solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure.

Education

  • MD, Pharmacist, PhD or master’s degree in Human Health Sciences

Experience

  • Minimum 4 years’ experience in managing Pharmacovigilance activities in close collaboration with key departments (Medical Affairs, Regulatory, Clinical, Quality Assurance, etc.) or equivalent experience.
  • Experience working in multinational environment, across diverse cultures
  • Experience working with PV systems in Sub-Sahara African countries
  • Experience with PV Agreements and or PV Partnerships and partner relations
  • Experience in transversal projects

Knowledge and Skills Desirable but not Essential:

  • Country PV experience is an asset.
  • Knowledge of other languages. Persian language is advantageous

What Sanofi Can Offer You

  • Benefits to enhance your life journey
  • Development opportunities to own your future
  • An open and inclusive environment where you can be yourself
  • Social activities and wellbeing programs to support your life

We do not stop there, Explore:

  • Hybrid Working Options (for Istanbul HQ and for eligible white collar positions at M&S site)
  • Comprehensive Medical Plan
  • Company Private Pension Plan 
  • Flexible Benefits Program for YOU to design your benefits
  • Company car for eligible positions & attractive lunch voucher/cafeteria at M&S site
  • Birthday Leave to celebrate YOU
  • 14-week Parental Leave
  • Employee Stock Purchase Plan dedicated to Sanofians
  • Kindergarten Allowance for female employees
  • Employee Assistance Program
  • Access to various learning & development resources, career development opportunities
  • AND MORE!

We chase the miracles of science to improve people’s lives.

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. 

Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to make the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our commitments.

We are one of the largest pharmaceutical companies in Turkey, serving public health for with more than 1,600 employees. Adding value to local economy and development in Turkey, we offer a broad range of products including innovative therapeutic solutions, biotechnological pharmaceuticals, vaccines, and consumer healthcare products.

Our factory in Lüleburgaz is one of the leading pharmaceutical manufacturing plants in Turkey. It is also among the top three Sanofi production sites worldwide in terms of its manufacturing capacity. Our manufacturing site, produces high-quality pharmaceuticals in many different forms in accordance with global health standards, and develops generic medicine at its on-site R&D Center.

Pursue progress.

#LI-Hybrid

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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