Director - PV Scientists Group - Medical Risk Management - Cubist Pharmaceuticals - Lexington

Job description
Position Summary:
The Director, Pharmacovigilance Scientists group (Dir. PVS) works closely with the Head of Medical Risk Management to lead and develop a group of PV Scientists (Nurses or Pharmacists) to support the Global Pharmacovigilance in its overall responsibilities to maintain or increase the safety of patients exposed to the company products. The Director will manage the activities, processes and priorities of the PVS group to deliver the best service and material allowing the Medical Risk Management MDs to act in the best interest of patient safety. These activities will include signal detection, safety and benefit-risk evaluations for assigned products, management of potential safety issues for assigned products, evaluation of databases for safety signals, and drafting of responses to regulatory inquiries on product safety issues.


Main responsibilities include:

Provides leadership to a number of PV Scientists (4-7), driving individuals to excellence in delivering and managing safety information.
Contributes to the development and implementation of a strategic vision for Pharmacovigilance across Cubist together with the GPV-MRM Leadership Team.
Ensure PV Scientists contribute as needed in close partnership with the MRM MDs to lead or contribute to all required activities requiring PV input or oversight (such as clinical study development programs or post marketing surveillance); Ensures that the business needs, format and timelines are met, and delivered on time and quality.
Leads the development of the Cubist Risk Management Plans and/or Risk Evaluation and Mitigation Strategies for all products in partnership with the MRM MDs. Leads PV Scientists contribution to clinical research and development planning in partnership with the responsible safety physicians.
Responsible for the development, authoring, and coordination of aggregate reports (PSUR, DSUR, IND annual, NDA annual, ad hoc reports, HHEs, etc.), contributing to different safety review or labeling committees, supporting the development of Company Core Safety Datasheet, REMS or RMPs.
Stays on top of PV knowledge, develop a learning organization mindset, focusing on compliance, performance metrics, and excellence in execution implement best business practices
Manages the performance and development of a group of Health Care Professionals.

Minimum Basic Qualifications:

PharmD, RN or MS with a minimum of 10 years of experience including 5-7 years of global PV experience, ensuring a deep understanding of the pharmaceutical environment, regulations and drug safety.
Minimum 5-7 years of experience in reporting, aggregate reporting preparation, signal detection, crisis management, organizational design and international exposure.

Preferred Qualifications:

Deep knowledge and experience with safety surveillance, signal detection, labeling analyses, and ad hoc safety analyses in multiple settings.
Significant experience with safety database systems, PV reporting obligations, MedDRA coding.
Significant experience in the reviews of relevant safety information from all sources and analysis of safety data.
Robust experience with development, authorship and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.), Risk Management Plans, and Risk Evaluation and Mitigation Strategies

Competencies/Skills:

Ability to lead and engage a team of professional behind a clear vision with impact on patients’ safety.
Ability to team work and contribute at tactical and strategic levels, driving results with excellence in execution.
Ability to establish critical and productive partnership with key functions inside or outside of GPV-MRM
Ability to leverage a deep understanding of oneself through knowing one’s strengths and weaknesses, proactively asking for feedback to balance self-perception, and being resilient in order to increase one’s effectiveness .
Ability to recognize opportunities and/or issues and applying analytical and creative thinking to maximize performance.
Being the champion of changes allowing to continuously improve practices and standards. Ability to work cooperatively with colleagues and take initiatives to build relationships despite differences in interest, offering support and help to peers without being asked or proactively seeking input from others to solve problems.
Ability to express ideas and information clearly and accurately. Excellent interpersonal, communication, and personal organization skills;
Ability to targeting one’s efforts on discovering and meeting an internal or external customer’s needs by ensuring timely follow through to customer inquiries or business issues, and being proactive in adding value to the customer.

Work Environment:

This is a Lexington-based position that requires significant interactions with internal colleagues from other departments and with external colleagues and consultants. Works within Cubist’s established policies and procedures and ensures alignment of their work with Cubist’s values.

Physical Demands:

Minimal travel may be required

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions

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