Sanofi Jobs

A new perspective. A new challenge. A new opportunity.

Job Information

Sanofi Group Periodic Report Planning Expert Consumer Health Care in Bridgewater, New Jersey

POSITION OVERVIEW

KEY RESULTS/ACCOUNTABILITIES

  • Accountable for ensuring adequate worldwide regulatory planning of Periodic Safety Reports in compliance with International and Local regulatory requirements and as per provisions of Safety Data Exchange Agreements with Global external Partners to ensure continued marketing authorization of Sanofi products globally

  • Ensure the planning is consolidated in a manner to meet all requirements and minimizing the number of reports written (thereby reducing the number of resources needed for writing reports and reducing outsourcing budget)Prepare and maintain schedule of global periodic reporting requirements for all products worldwide based on local / international regulatory requirements: For Post-Marketing products: Analysis of EURD list and identification of impact on Master Planning Table - -Closely work with CSL/GRA colleagues to collect information about renewals. For products under development: In addition to GRA colleagues and CSO/CSL/GSO, closely work with SDEA team to ensure efficient PSR Planning

  • Provide support in gathering, analyzing, consolidating and presenting key data and information required for effective planning and management of all activities related to periodic reporting

  • Participate in the preparation/update of quality documents and training materials impacting planning

  • Support product/portfolio, acquisitions, and divestments

KEY WORKING RELATIONSHIPS

  • Affiliate organizations

  • Health Authorities

  • PSR Authoring Team

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

  • PharmD with a minimum of 3 years of pharmacovigilance experience or Bachelor’s Degree with at least 5 years’ experience in pharmacovigilance

  • Fluent in English

  • Ability to solve problems and take initiative, meet challenges, and strong negotiation skills

  • Strong knowledge of worldwide pre and post marketing safety reporting regulations and requirements and ICH guidelines

  • Ability to work in a global, multi-entity, multi-cultural environment across timezones

  • Excellent teamwork and collaborationskills

  • Pharmaceutical industry experience, especially inpharmacovigilance

  • Capability to organize and multitask activities, effectively prioritize and allocate resources

  • Computer literacy especially in Windows basedprograms

  • Ability to solve problems, to takeinitiative, to meet challenges, negotiationskills

  • Excellent written and oral communicationskills

  • Ability to effectively work with others throughout theorganization, primarily affiliates

Key Dimensions

  • Leadership, Teamwork and Management skills;

  • Good interpersonal and negotiator skills

  • Excellent Project management skills

  • Strong decision making skills

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA

#LI-SA

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.

DirectEmployers