Director, Pharmacovigilance

Supports Global Pharmacovigilance with an emphasis on a selected investigational or marketed product.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 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 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 managementQUALIFICATIONSBASIC 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.