Vertex Pharmaceuticals
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Cambridge,
MA
The Medical Director/Associate Director, Global
Patient Safety will be responsible for leading medical pharmacovigilance
activities for development products and/or products in post-marketing. Primary
Responsibilities include: safety assessments and surveillance, compliant
regulatory authority reporting, benefit-risk assessments and communication of
safety information. He/she will serve as an expert to internal staff and
external constituents, leading the provision of key clinical, operational and
strategic input around safety matters. He/she will also be responsible for the
assessment of benefit-risk information, evaluation of safety signals and
formulation of responses to regulatory inquiries. He/she will ensure effective
collaboration across functions, collaborate to advance clinical development
programs representing the department and will function as a point person for
pre- and post-marketing safety issues.
Represent department as
medical safety lead, on cross-functional study and program teams for assigned
products and studies, providing expert guidance regarding safety and
Risk-Benefit related issues.
Medically review individual
case safety reports from clinical trials for assigned products as required.
Conduct medical evaluation of
other relevant safety information, such as from non-clinical studies and
product quality complaints.
Participate in protocol
development, specifically protocol design and statistical analysis plans, of
clinical trials.
Provide expertise for developing procedures to capture, manage and report
clinical trial safety data.
Participate in the analysis
of safety data from on-going and completed clinical trials and representation
in Clinical Study Reports
Contribute to preparation and review of periodic reports (IND, Annual Safety,
PSUR)
Review and provide medical content for key study-related documents, e.g. IB,
ICF IDMC Charter.
Oversee investigational and
post-marketing regulatory reporting and pharmacovigilance activities for
assigned products.
Participate in departmental
development activities including SOP and Work Instructions development.
Provide guidance to staff
regarding optimal practice regarding collection, evaluation and processing of
adverse experience reports, from a medical perspective.
Provide a contributory role in Partner /Affiliate agreements and interactions,
as needed.
Oversee, prepare Dossier/Submission related documents including but not limited
to PSURs, NDA Periodic reports
Oversee, prepare, and review responses to ad hoc regulatory queries, and
signaling topic reports
Minimum Requirements
M.D. required; 3+ years of
pharmaceutical pharmacovigilance experience, ideally both pre- and
post-marketing.
- Solid knowledge of general medicine and clinical practice, evidenced by
medical training and/or medical practice experience.
- Strong leadership skills, as well as experience working in a matrix
environment.
- Must have a strong working knowledge of FDA regulations/ICH guidelines
- Must be experienced in safety reviews of IBs, protocols, final clinical study
reports, and summaries of safety.
- Advanced ability to read, analyze and interpret clinical data and information
- Possess very strong writing skills and advanced verbal communication and
presentation skills.
- Requires strong attention to detail in writing and/or proofing materials
- Ability to work in a fast paced environment with demonstrated ability to
simultaneously manage multiple competing tasks and demands.
- Ability to work independently, take initiative and complete tasks to
deadlines.
- Occasional domestic and international travel may be required (<10%).
Cambridge, MA
Cambridge, Massachusetts
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