Director, Global Safety Officer / R&D15764 Job in Cambridge 02138, Massachusetts Us

Sanofi-aventis is facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class RD organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines. Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.

Position Description:

Job Summary
The primary function of the Global Safety Officer's (GSO) role is to identify and effectively manage potential safety issues:
• for products under clinical development
• for marketed drugs, medical devices and PTCs

The GSO is the reference person within GPE for products he/she is in charge of:
• to prepare and validate documents intended for stake holders,
• to serve as a pharmacovigilance (PV) Expert.

Risk Assessment / Benefit-Risk Assessment:
Lead aggregate safety data review activities, coordinate safety surveillance activities.
Responsible for proactive risk assessment.
Key PV contact in interaction with relevant functions involved in benefit-risk assessment.
Responsible for interfacing with individuals and functions who are responsible for assessment of therapeutic benefits.
Signal Detection and Analysis:
Accountable for leading Safety Management Teams, if applicable.
Responsible for signal detection and analysis by working with, for example, the GPE Signal Detection and Epidemiology groups.
Develop proactive safety analysis plan and propose actions to further define the safety profile.
Risk Management:
Develop Risk Management strategies and support GPE Risk Management group.
Provide medical and safety input into Development Risk Management Plans and Risk Management Plans.
Submission Activities:
Represent PV position in submission teams and ensure consistency and adequacy of safety in submission documents.
Provide appropriate contribution to health authorities' questions.
Support preparation and conduct of Advisory Committee meetings.
Periodic Reports:
Documentation, Coordination, Review and validation of Periodic reports, e.g.: RMP update, IND update, Annual Safety Report, Periodic Safety Update Report.
Serve as the medical safety expert to the GPE Periodic Reports group for assigned projects and products.
Individual Case Safety Reports:
Medical aggregate review of Individual Case Safety reports.
Validation of SUSARs/serious unlisted before distribution to competent Authorities/affiliates/partners
Oversight and interpretation of ICSRs in context of overall safety profile
Support:
Provide pharmacovigilance support to internal customers, including those within GPE, e.g. Devices, Periodic Reports, RMP, SDEA groups, etc.
Serve as an expert for all pharmacovigilance issues.
Serve as the GPE representative to assigned Project and Product Teams.
Represent PV position in internal and external negotiations such as Competent Authorities, Ethics Committee, Healthcare professionals, Partners
Internal Communication:
Inside GPE and inside project/product teams
External communication:
Competent Authorities, Ethics Committee, Healthcare professionals, Partners etc.
Knowledge:
Acquire and maintain knowledge for concerned product and product environment including preclinical and clinical dossier of products as well as general medical knowledge, pharmacovigilance expertise and international safety regulations and guidelines for drugs and devices
Literature review:
Ensure appropriate literature review to support assessment of safety profile.

Decision Making Authority
Authority to :
• Identify potential signals/issues of pharmacovigilance and evaluate product safety,
• Recommend/discuss and coordinate appropriate course of action.
• Ask project/product team for necessary amendments, labelling modifications/variations
Information/Decisions to be referred to hierarchy:
• Transmission of any decision with impact on Study Conduct (e.g. Clinical Hold)
• Transmission of any safety concerns for which GSO is informed (e.g. Health Authority restriction/decision…)
1.Internal: other GPE Units, RD Units, Scientific Core Platforms, International Development, Medical and Regulatory Affairs, Franchise(s), Legal Department, Communication, Affiliates (APH)
2.External: Regulatory/Competent Authorities, Ethics Committee, Investigators, Data Monitoring Committees, partners, CROs

Qualifications:

Knowledge and Skills
Excellent clinical judgment and capability to synthesize data from several sources is required. Ability to assess and communicate complex clinical and scientific issues in a scientifically sound and understandable way, in both verbal and written formats, is required. Previous experience writing complex, critical, clinical analyses preferred. Demonstrated initiative, ability to formulate and lead investigative plan, ability to develop and document sound risk assessment and minimization recommendations taking into account benefit-risk assessment and relevant guidance documents and regulations, and capability to work under pressure are required. Excellent teamwork and interpersonal skills are required.
Fluent in English (written and spoken).

Formal Education and Experience
M.D. Degree is required. Board Certified/Board eligible, or equivalent, is preferred with minimum 3 years total experience in international pharmacovigilance, or equivalent relevant industry experience (e.g. clinical development) with relevant clinical experience as required by the specific position. Candidates may be considered if they have proven excellence in a similar position before, even if they have less than 3 years international PV experience.

Knowledge and Skills Desirable but not Essential
Prior Competent Authorities submission with safety data analysis is expected