Dir, Pharmacovigilance

Job Description:Company Information:Breakthrough Careers!A career at Millennium comes with something no other company can offer: a community of people with diverse talents and backgrounds, all dedicated to the discovery and development of therapies that can change the world - one patient at a time. Our casual but focused environment fosters the free exchange of ideas, encourages collaborative research, and sparks discovery of innovative solutions in science and business. At Millennium, we're big on results, not formality.Position Summary:Support Global Pharmacovigilance by serving as a resource for the Medical Information and Quality Control Teams and as named Drug Safety Medical Advisor for selected drug.Duties and Responsibilities:Communicate effectively in safety matters with Regulatory Affairs, Clinical Teams, Statistics, Data Management, Marketing, and the Legal Department.Provide advice regarding investigations or special questions regarding safety of investigational and marketed products.Handle adverse events according to national and international regulatory requirements.Ensure adequacy of recording, summarizing, and handling of adverse events for marketed products including decisions on seriousness and expectedness.Ensure accuracy and timelines of expedited and periodic reports from postmarketing safety surveillance.Ensure accurate coding of adverse events.Ensure due diligence in characterizing adverse events.Implement formal signaling procedures.Characterize expected rates of key adverse events in target populations.Participate in product labeling decisions.Provide expert advice specifically on safety-related issues concerning investigational compounds, marketed products, and Phase IV Trials.Ensure effective communication on safety matters with Clinical Research, Preclinical Research, Project Management, Regulatory Affairs, Marketing Strategic Planning to ensure effective interactions and exchange of all relevant information.Keep management informed of special concerns and developing safety problems with investigational compounds and marketed products.Collaborate with consultants concerning drug safety issues and pharmacoepidmeiology studies.Ensure adequacy of recording, summarizing, and handling of serious adverse events from clinical trials including decisions on seriousness, expectedness, and causality.Ensure accuracy and timelines of expedited and periodic reports from clinical trials.Oversee review of safety sections of clinical trial protocols, investigator brochures, and informed consents.Provide strategic input to and in certain instances lead safety analyses including but not limited to investigator letters, periodic reports on marketed and investigational products, clinical trial protocols, investigator brochures, and Integrated Summaries of Safety.Work with Clinical Teams, Project Management and interface with CRO Safety.Perform such other duties as requested by management.Qualifications:Basic Qualifications:Graduate of recognized, accredited medical school. At least 4 years in the pharmaceutical and biotech industry. Must have knowledge and understanding of clinical trials and previous healthcare and clinical experience. Preferred Qualifications:Previous MedDRA or GCP training preferred.Click here to immediately applyWant to learn more about us? Years of Experience Required: 3-5 YearsExpected Travel Time: None Searchable Keywords: SAS / gj-moExpected Travel Time: None Company: Millennium Pharmaceuticals, Inc. Contact: Recruiter Email: Apply by Email Address: 02454 Reference Code: 14467.26412.5426BR Company: Millennium Pharmaceuticals, Inc. Status: Full Time, Employee Job Category: Biotech/R&D/Science