Job Description

Kelly® Science & Clinical  is seeking a Pharmacovigilance Manager/Physician for a fulltime, long-term contract position with a large CRO. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust  The Experts at Hiring Experts.

Summarized Purpose:

Advanced leadership responsibilities within the Pharmacovigilance (PV) physician team which may include direct line management accountability. Works collaboratively and serves as the primary point of contact between the PV physician group and other PV leaders (MPC group leadership, etc). Provides leadership and strategy to multidisciplinary teams within PV and across the company, not limited to PV operations, training development, business objectives, quality initiatives and management, process improvement, compliance, and innovation. Applies therapeutic area expertise and indication-specific knowledge to provide medical consultation and strategic direction, and risk mitigation strategies to internal teams and clients. Supports business development activities. Manages (direct-line or matrix), mentors, and oversees PV physicians globally to support training and end to end medical monitor and/or safety physician activities and supporting services across the pharmaceutical product life cycle. Encourages a culture of accountability and continuous process improvement. Develops and manages resource allocation plans and budgets. Serves as the PV physician team liaison with other departments and clients. May provide oversight of medical review and analysis of data for clinical trial serious adverse events, aggregate review (e.g.,trending and listings), marketed products ICSR and periodic safety reports (e.g., PBRER, PSUR, DSUR), and other client deliverables (e.g., labeling reconciliation documents, CTD modules, REMS, RMP, signal detection reports and CSR).

Essential Functions

• Provides global and regional medical leadership, mentoring and oversight to direct reports (if applicable) and global PV physician team. Serves as consultant and spokesperson of PV physician team or external spokesperson for the PV organization on significant matters.
• Utilizes subject matter clinical and pharmacovigilance expertise, combined with knowledge of the product(s) or therapeutic area to interpretation of safety and efficacy data, therapeutic and protocol training, identify and evaluate safety signals and to drive decision-making on risk/benefit evaluation and argumentation, pharmaco-epidemiological or clinical trial data interpretation, and risk assessment, if applicable.
• Creates formal networks with key decision makers. Collaborates with crossfunctional group leaders to develop, promote, and contribute to strategic process improvement initiatives and planning of training and development programs.
• Serves as the primary point of contact for activities related to quality and reporting compliance of safety reports, and as subject matter expert for these topics during audits and inspections.
• Assists in the development and implementation of policies to enhance the effectiveness of the PV department. Identifies unusual or significant issues related to safety and/or medical monitoring processes and proposes prevention and/or correction strategies.
• Provides insight and participates in new business/business development strategy calls, proposal development, bid reviews and parameters for business deliverables.
• Provides global leadership in medical safety and risk mitigation activities for projects and clients (e.g., primary point of contact), foster client relationships and supervises strategic sell initiatives of the PV department. Provides expertise and oversight of study start-up activities for medical deliverables. Communicates with sponsors to obtain direction and feedback on implementing program scope of work and performance.
• Actively participates in recruiting efforts and selection process.
• If applicable, provides new hire onboarding, salary administration, performance management, promotion and discharge activities, and conflict resolution.
• Maintains understanding of contracts and budgets, methods for recording time spent on project and administrative tasks, expense submissions and travel.
• If applicable, attends and contributes at MD management and allocation calls.
• Cultivates a supportive, motivating, and collaborative work environment. Builds an effective and productive team focused on overall corporate deliverables. Helps ensure projects and initiatives align with company culture.

Education and Experience:

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years).
• 8+ years of management responsibility
• MD or equivalent required.
• Active medical licensure preferred.
• Candidates should have a combination of clinical experience and industry experience as follows:

*Subspecialty training in nephrology and/or board certification/board eligibility in nephrology or meaningful clinical experience in treating patients in the specialty (comparable to 2 years)

Suitable clinical development experience in a Contract Research Organization or pharmaceutical company (comparable to 2 years), preferably in nephrology

Direct experience in safety/Pharmacovigilance (comparable to 2 years).

Knowledge, Skills and Abilities:

• Therapeutic and indication-specific development expertise across one or more therapeutic areas
• and/or one or more drug classes, including deep knowledge of clinical program and study design,
• relevant endpoints, safety considerations, and current regulatory and commercial landscape
• Deep knowledge of important regulatory considerations governing adverse event reporting and
• experience with FDA, EMA and other national and international regulatory authorities
• Experience as a medical strategy leader for multidisciplinary teams with mastery of medical
• management tasks (review AEs, protocol inquiries, listings, diagnostic reports, data trending, etc.)
• and/or safety tasks (signal detection activities, aggregate report generation, label update
• contribution, dossier maintenance support, and risk management activities)
• Thorough understanding of guidelines for marketing authorization submissions and international
• guidelines for conduct of clinical studies
• Strong decision-making, negotiation, and analytical skills
• Excellent communication and influencing skills
• Excellent organizational skills and detail-orientated leadership approach
• Ability to tactfully supervise and objectively evaluate medical staff
• Ability to mentor effectively in both one-on-one and in group settings
• Flexibility to travel domestically and internationally
• Ability to work independently on multiple tasks in a fast-paced environment
• Proficient in basic computer applications
• Overall knowledge of the drug development process
• Ability to effectively manage direct reports (if applicable

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