eNewsletter Signup
Miles
Km80.5

Director, Pharmacovigilance (PV)

Millennium: The Takeda Oncology Company

Apply
E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: Cambridge, MA Posted Date: 4/24/2013 Position Type: Full time Job Code: 7387BR Required Education: High school or equivalent Areas of Expertise Desired: Pharmacokinetics

Description

We Aspire to Cure Cancer! Millennium is a leading biopharmaceutical company focused on oncology that combines the agility, ideals and camaraderie of a start-up with the resources of Japans largest pharmaceutical company. The result is a creative, entrepreneurial environment where quality science and making a difference in patientslives are the priorities. Here, employees who share a drive and commitment to innovation for the benefit of oncology patients find their ideas, experience and contributions are valued and rewarded. Millennium offers great benefits, a friendly and respectful atmosphere, and a culture that promotes flexibility between work and life and encourages employees to give back to their community.

POSITION SUMMARY:

The Pharmacovigilance & Risk Management Late Stage Team is composed of subject matter experts who are knowledgeable, passionate and efficient in providing high-quality and timely safety-related deliverables. We seek a committed Global Safety Leader to join this exciting team, dedicated to ensuring the safety of our patients.

DUTIES & RESPONSIBILITIES:

Support Global Pharmacovigilance Serve as a resource for the Medical Information and Quality Control teams Serve as named clinical safety medical advisor for selected drug development programs Assist and support the activities of the Vice President, Pharmacovigilance Communicate effectively in safety matters with Regulatory Affairs, Clinical Teams, Statistics, Data Management, Marketing, and the Legal Department Provide advice regarding investigations of 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 timeliness of expedited and periodic reports from postmarketing safety surveillance Ensure accurate coding of a
dverse 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 on medical matters in general, and specifically on safety-related issues concerning investigational compounds, marketed products, and postmarketing trials Ensure effective communication in safety matters with Clinical Research, Nonclinical Research groups, Project Management, Regulatory Affairs, and 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 pharmacoepidemiology 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 timeliness of expedited and periodic reports from clinical trials Review safety sections of clinical trial protocols, investigator brochures, and informed consents for selected drug development programs 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 and Project Management and interface with CRO Safety Perform such other duties as requested by management

Requirements


BASIC QUALIFICATIONS:

M.D. degree or equivalent At least 2 years in pharmaceutical medical research with at least 1 of those years spent in product safety/pharmacovigilance/benefit-risk optimization MedDRA training GCP training Individual Case Safety Report handling, as well as periodic report, PSUR and variation preparation Practical clinical experience/expertise Expertise in clinical research and safety activities in a pharmaceutical/biotech company Practical experience working with MedDRA Ability to interact effectively with staff of multiple disciplines both within and outside the company both nationally and internationally Ability to manage/supervise activities in a high-pressure, fast paced and changing environment to ensure objectives are met in a timely manner and achieved within budget allocations

PREFERRED QUALIFICATIONS:

Graduate training/experience resulting in board eligibility/certification Postgraduate training in clinical epidemiology and biostatistics Specialization and experience in gastroenterology/hepatology, nephrology, hematology, dermatology, neurology, intensive care, oncology, inflammation, or clinical pharmacology Experience/expertise in pharmacoepidemiology research Other: Nature of the department and the information that flows through the group requires that the individual be able to work well and communicate effectively with people both inside and outside of the department in order to meet deadlines. Person needs to be able to adapt to the changing dynamics in workflow and react accordingly. Due to the sensitive nature of the data received, person must have integrity when handling the confidential data.
Apply
E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS