[Remote] PV Manager Safety Science at Thermo Fisher Scientific

Serbia

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Bachelor's degree or equivalent and relevant formal academic/vocational qualification
3+ years of safety experience (including signal detection, aggregate safety report writing or other safety science tasks)
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
1+ year of leadership responsibility, which may include serving as a project lead

Responsibilities

Coordinates contracted safety responsibilities for one or more programs, including staffing, training, procedural compliance and technology oversight
Manages the safety team on respective programs
Works with senior management and develops consistent internal processes and ensures compliance with established processes
Proactively liaises with project leads and clients to ensure optimal performance and utilisation of the safety project team and delivery of a high quality service to clients
Directly fulfils safety scientist activities on assigned projects
Oversees a multinational team of safety scientists
Oversees maintenance of applicable technology platforms
Manages multiple aspects of projects, both local and globally, such as contractual, procedural and regulatory requirements
Maintains good communications with other functional groups concerning program and company issues
Collaborates with other employees in problem solving and systems improvement
Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals
Maintains a basic understanding of applicable therapeutic area and disease states
May participate in on-call duties for specific projects
Provides plans and accurate forecasts for all assigned projects
Serves as a resource to other departmental managers and leads departmental initiatives
Prepares and presents proposals
Manages staff of experienced professionals, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counselling, and separations
Approves courses of action on salary administration, hiring, corrective action, and terminations
Reviews and approves time records, expense reports, requests for leave, and overtime
Proactively monitors and manages utilization of individual team members
For assigned projects, serves as a safety scientist creator/contributor for signal detection, aggregate safety report writing and/or other product safety science tasks

Skills

Key technologies and capabilities for this role

PharmacovigilanceSafety ScienceCase ProcessingRegulatory ReportingMedical MonitoringClinical TrialsTeam ManagementProcedural ComplianceStaffingTraining

Questions & Answers

Common questions about this position

What benefits does Thermo Fisher Scientific offer?

The company offers continued career advancement opportunities, award-winning training, and benefits focused on the health and wellbeing of employees.

Is this a remote position or does it require office work?

The position is based in office environmental conditions with a standard Monday-Friday work schedule.

What are the key responsibilities or skills needed for the PV Manager Safety Science role?

The role involves overseeing a multinational team of safety scientists, managing safety responsibilities for programs including staffing and training, ensuring procedural compliance, and directly fulfilling safety scientist activities on projects.

What is the company culture like at Thermo Fisher Scientific?

The culture emphasizes hiring the best, developing ourselves and each other, recognizing the power of being one team, and providing resources for career goals in a goal-oriented environment.

What makes a strong candidate for this PV Manager role?

Strong candidates will have experience managing staff of experienced professionals, overseeing multinational teams, ensuring compliance with processes, and collaborating across functional groups, along with knowledge of pharmacovigilance regulations.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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