Pharmacist Job In Wayne, Pennsylvania
Associate Director, Pharmacoviligance SciencesNext Steps... Apply Now
Job ID 2019-1950
# of Openings 1
Category Pharmacovigilance - Dept
This role is part of the pharmacovigilance sciences function within the department and includes working with the PV physician on all aspects of medical surveillance and risk management activities for investigational and marketed products. This role will report into the Executive Director of PV Sciences and works cross-functionally with internal/external key stakeholders and external resources on pharmacovigilance-related matters.
- Responsible and accountable for assigned product or therapeutic area pharmacovigilance activities.
- Compile pharmacovigilance aggregate reports (e.g. DSUR, PBRER, topic reports) working with safety physician and ensure effective planning such that stakeholder input is requested/received for applicable sections of the report meeting regulatory timelines.
- Write relevant sections collaborating with safety physician
- Provide training and guidance to other functions to address ad hoc questions and issues pertaining to pharmacovigilance safety reports
- Work with safety physician to compile safety information for Clinical Overviews, responses to regulatory questions, post-marketing safety assessment, Risk Management Plans, labeling justifications, CCSI development, IB update, label update as well as written summaries of clinical safety of common technical document.
- Assume lead role in review and approval process for all pharmacovigilance reports working in conjunction with safety physician and external pharmacovigilance vendor.
- Work with the safety physician to ensure all information is available to allow for informed medical review and benefit-risk assessment of assigned product/s.
- Conduct safety surveillance and signal detection activities for Radius products working in conjunction with safety physician.
- Responsible for scheduling and administration of routine and ad-hoc Safety Review Team (SRT) meetings and that stakeholder provide input from their respective areas of responsibility.
- Ensures that regulatory and RMP commitments are efficiently tracked and presented as part of the SRT process. Liaises with SRT chair to facilitate communication and support for decisions resulting from the SRT (e.g. update of RMPs, labeling, regulatory notifications).
- Collaborate with stakeholders outside of PV and attend cross-functional clinical programs and registration activities and provide support to clinical developmental programs.
- Collaborate with medical monitor(s), safety physician and Regulatory Affairs to process, review, submit, track and monitor expedited safety reports to appropriate domestic and international regulatory authorities.
- Provide support to Drug Safety Monitoring Board.
- Provide oversight and contribute to draft, review and track of safety data exchange agreements and pharmacovigilance agreements with Radius Alliance partners.
- Contribute to training and oversight to pharmacovigilance vendor supporting pharmacovigilance activities for Radius investigational and marketed products.
- Maintain a thorough understanding of clinical protocol(s) and the scope of work for assigned projects.
- Contribute to PV process improvements, standard operating procedures (SOPs), tools, etc., pertaining to pharmacovigilance activities.
- Support PV audits and inspections. Participate in audit preparedness activities and serve as subject matter expert during regulatory inspections in collaboration with team members.Perform other tasks and assignments as needed and specified by management.
- BSN/RN, Bachelor's degree in Pharmacy, PharmD, or PhD and a minimum of 10 years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment is required.
- Experience in signal detection, safety surveillance, risk mitigation and risk management is preferred.
- Expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance is required.
- Extensive working knowledge of medical terminology and Medical Dictionary of Regulatory Activities (MedDRA).
- Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality is important.
- Proficiency with Microsoft Office and excellent verbal and written communication and skills.
- Ability to work independently and collaboratively, as required, in a fast-paced matrixed team environment consisting of internal and external team members.
- Analytical thinker with excellent problem solving skills and the ability to adapt to changing priorities and deadlines.
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
- Expertise in the use of Electronic Document Management System (eDMS) software is preferred.