Manager Pharmacovigilance/Drug Safety

Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzyme Corporation has been selected by FORTUNE Magazine as one of the "100 Best Companies to Work For in 2007 in the United States”. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.
We currently have an opening for an experienced Manager to head the Pharmacovigilance (PV) Transplant Team.
This is an exciting opportunity to gain experience of an established, stable and complex product line that is expanding indications and market reach into new global markets.
The Manager assumes responsibility for hiring, evaluating, and developing PV Operations Transplant team.
The Transplant Manager will:
• provide direction and guidance regarding the gathering, evaluation, and processing of adverse event reports for assigned products.
• collaborate with Global Safety Officers and Medical Staff on key program activities, concepts and timelines and coordinates activities with other departments for the completion of regulatory documents (e.g., protocols, IBs, ASRs, CSRs, ISS, periodic reports, labeling and promotional material review, responses to questions from global agencies).
• be responsible for the collections and analysis of relevant safety information in collaboration with the Global Safety Officer(s).
• act as key PV Operations expert to collaborate with other Genzyme therapeutic areas and departments including R&D, BioMedical Operations, business partners, Global PV Systems and other global colleagues.
• delegate appropriately to team members and ensures team compliance with AEs reporting procedures (e.g., monitors workflow).
• participate on projects which enhance team and/or division performance.
• prepare and conducts performance appraisals for direct reports.

Basic Qualifications:
Bachelor’s degree in health related field with minimum of 5-7 years of Pharmaceutical/Biotechnology industry or Contract Research Organization experience in pharmacovigilance and a minimum of 3 years experience leading and mentoring teams.

Additional Requirments / Information

Job Capacity:	Employee (full-time)
Minimum Education Level:	See Job Description
Visa Sponsorship:	No
Related Industries:	Biotechnology

One of the world's foremost biotechnology companies, Genzyme is dedicated to making a major positive impact on the lives of people with serious diseases. Founded in Boston in 1981, Genzyme has grown from a small start-up to a diversified enterprise with annual revenues exceeding $2 billion and nearly 7,600 employees in locations spanning the globe.

With many established products and services helping patients in more than 80 countries, Genzyme is a leader in the effort to develop and apply the most advanced technologies in the life sciences to address a range of unmet medical needs. The company's products and services are focused on rare inherited disorders, kidney disease, orthopaedics, transplant and immune disease, cancer, and diagnostic testing. Genzyme's commitment to innovation continues today with a substantial research and development program focused on genetic diseases, immune system disorders, heart disease, and cancer.

What drives Genzyme's success is the broad range of perspectives and diverse backgrounds among our employees. Their inspiration and ideas are focused on creating innovative solutions for today's toughest medical challenges. If your passion for impact rivals your dedication to helping others, Genzyme offers a workplace unrivaled in the industry that will help you achieve your goals.

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