Thermo Fisher Scientific Jobs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Discover Impactful Work:

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.

Serves as the PV physician team liaison with other PPD 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).

A day in the Life:

• Provides regional medical leadership, mentoring and oversight to direct reports 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 cross-functional 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.

• 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.

• 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.

Keys to Success:

Education and Experience:

MD required. History of an active medical license highly preferred. Candidates should have:

• Clinical experience in having direct responsibility for diagnostic and treatment decisions (comparable to 3 years);

• Direct experience in medical review and assessment of safety information/Pharmacovigilance (comparable to 2 - 3 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

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.