Safety Specialist - FSP

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.

Location and Division Specific Information

Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical trials, oversee case-processing activities through all phases of development and perform regulatory reporting and medical monitoring.

This is a remote role based in India.
 

Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/ reporters, and third party vendors. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.
 

As part of your work with beginning-to-end trial experience, you will expand your knowledge and experience working on clinical trials through every stage of drug development. This includes management and oversight of all contracted services.

• Performs day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.

  
  

• Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals. Maintains medical understanding of applicable therapeutic area and disease states.

  
  

• Reviews cases entered for quality, consistency and accuracy, including review of peer reports.

  
  

• Prepares and maintains regulatory safety reports.

  
  

• Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less expert staff.

  
  

Education and Experience

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

• General understanding of pathophysiology and the disease process

  
  

• Detailed knowledge of relevant therapeutic areas as the need arises for processing AEs

  
  

• Strong critical thinking and problem solving skills

  
  

• Good oral and written communication skills including paraphrasing skills

  
  

• Good command of English and ability to translate information into local language where required

  
  

• Computer literate with the ability to work within multiple databases

  
  

• Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)

  
  

• Understanding the importance of and compliance with procedural documents and regulations

  
  

• Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision

  
  

• Strong attention to detail

  
  

• Ability to maintain a positive and professional demeanor in exciting circumstances

  
  

• Ability to work optimally within a team to attain a shared goal

  
  

Physical Conditions/Work Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

  
  

• Able to work upright and stationary for typical working hours.

  
  

• Ability to use and learn standard office equipment and technology with proficiency.

  
  

• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

  
  

• May require travel.(Recruiter will provide more details.)
   

  
  

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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.

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.

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