AVP, Medical Safety

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are 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 R&D 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.. Monitors the safety profile of the registered/marketed products in collaboration with Global Pharmacovigilance and Epidemiology (GPE). Oversees the affiliate clinical/medical assessment for all individual adverse reactions and product technical complaints leading to adverse events. Acts to detect and evaluate potential safety signals and develops the safety management plan in collaboration with the Head, US Affiliate Pharmacovigilance and GPE. Manages the group of Affiliate Safety Officers (ASO) responsible for preparing the US periodic reports. In collaboration with the Head, US Affiliate Pharmacovigilance and Global Pharmacovigilance and Epidemiology, provides local validation of all safety communications with internal or external customers. As requested, may coordinate Pharmacovigilance surveys and provide expert advice to internal/external customers regarding safety profiles of sanofi-aventis products.
and regulatory statutes for all company-marketed products, NDA Submissions and compassionate use Clinical Trials.
Ensure all reported adverse events are appropriately documented and relevant trends identified.
Ensure provision of medically/clinically sound alternative explanations for adverse event sequence(s), where appropriate.
Ensure effective liaison with Legal Department, Regulatory Department and Medical Affairs, regarding provision of medical expertise concerning reported adverse events, adequacy of information in promotional material fair balance statements and development and conduct of Clinical Trials as it relates to collection and analysis of safety data.
Ensure effective interpretation of epidemiological data derived from drug surveillance.
In the absence of the Head, US Affiliate Pharmacovigilance, serves as primary contact between regulatory agencies and company regarding Pharmacovigilance issues for marketed products and NDA Submissions.
Provide expertise regarding reporting obligation and contributes to the optimization of the process within USPV.
Responsible for the growth and development of the team of MDs under his/her management, and the maintenance of the best knowledge in pharmacovigilance and medical expertise.
Review and comment clinical trial protocols as needed for the safety sections.
Remain current on all Pharmacovigilance issues and ensure company continued compliance.
Participates and attends all relevant meetings/educational seminars to ensure that knowledge of pertinent medical or Pharmacovigilance issues is up to date.
Manage and provide developmental guidance for ASO in the group.
Demonstrate required Competencies on consistent basis.
Demonstrate company Values on consistent basis.
Perform other duties as requested.
REQUIREMENTS
Education:
. Medical Degree from an accredited US or foreign medical school with three or more years of postgraduate medical training.
. Board certification or eligibility preferred.
. Clinical practice preferred.Experience:
. Progressive experience in Pharmaceutical or Biotech Industry working in Medical Affairs and/or Pharmacovigilance, Drug Safety or related fields totaling eight to ten years.
. At least three years of experience managing other physicians.
. Knowledge of legacy Aventis products would be a plus.
. Experience with FDA reporting obligation is mandatory.Professional Skills:
. Extensive clinical knowledge in pertinent medical area(s)
. Ability to present complex information to others effectively
. Strong interpersonal, verbal and written communication skills
. Strong understanding of FDA and other Health Agency regulations regarding postmarketing surveillance.Job Specific Competencies:
. Considered medical expert on Safety Surveillance issues for sanofi-aventis marketed products.
. Ability to lead a functional discipline with resources fully allocated to medical teams.
. Ability to work with project teams to achieve best performance.
. Ability to be an effective team member and play a leadership role in a cross functional Medical Affairs department.Language:
English. French preferred.