Safety Specialist

1 month ago

Hyderabad, India Thermo Fisher Scientific Full time

Job Description

Job Description

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. 

Essential  Functions 
· 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 experienced 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). 
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. 


Knowledge, Skills and Abilities: 


· General understanding of pathophysiology and the disease process 
· Detailed knowledge of relevant therapeutic areas as required 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 challenging circumstances 
· Ability to work effectively within a team to attain a shared goal

  • Sr. Safety Specialist

    1 week ago

    hyderabad, India Statistics & Data Corporation (SDC) Full time

    Sr. Safety Specialist SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that...

  • Safety Specialist

    3 weeks ago

    Hyderabad, Telangana, India Thermo Fisher Scientific Full time

    Job DescriptionJob DescriptionPerforms 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...

  • Safety Officer

    4 weeks ago

    Jeedimetla, Hyderabad, Telangana, India Aerospace Engineering PVT LTD Full time

    Bachelor’s degree in safety, occupational health and safety, industrial hygiene or a related field. - 3+ years of experience in a safety-related role, preferably in an Indian context. - Relevant certifications such as Certified Safety Professional (CSP), Certified Hazardous Materials Manager (CHMM) certification or Certified Fire Protection Specialist...

  • Drug Safety Associate

    4 weeks ago

    Jubliee Hills, Hyderabad, Telangana, India virtuehire recruitment private limited Full time

    Hiring Pharmacovigilance(PV) Specialists with 1-2 years of experience. Preferably looking for immediate joinees. Key Skills: Argus Safety Database, Post Marketing Surveillance, Eudravigilance, XML Handling A new-age clinical services client in Jubilee Hills, Hyderabad hiring PV specialists. Their spectrum of services includes Clinical Trial Safety...

  • Environment, Health and Safety Manager

    2 weeks ago

    Hyderabad, India Hammond Power Solutions Full time

    The position is responsible for planning, developing, implementing and directing health and safety programs and activities throughout the Company to evaluate, prevent, control, or correct unsafe physical and environmental working condition and hazards.The job responsibilities include:- Safety related upgrades/changes with the Manufacturing Engineering group...

  • Environment, Health and Safety Manager

    2 weeks ago

    hyderabad, India Hammond Power Solutions Full time

    The position is responsible for planning, developing, implementing and directing health and safety programs and activities throughout the Company to evaluate, prevent, control, or correct unsafe physical and environmental working condition and hazards.The job responsibilities include:Safety related upgrades/changes with the Manufacturing Engineering group...

  • Executive - Environment Health & Safety

    6 days ago

    Hyderabad, India Promea Therapeutics Full time

    Full-Time (Hyderabad ) 1 to 2 Experience **Environment Health & Safety**:** Roles and Responsibilities** Their major role of EHS manager or office is to prevent and eliminate injury and sickness to the employees. They assist companies to comply with safety laws in systematic and organized approach. They periodically inspect workplace and machinery to...

  • Environment, Health and Safety Manager

    2 weeks ago

    Hyderabad, India Hammond Power Solutions Full time

    The position is responsible for planning, developing, implementing and directing health and safety programs and activities throughout the Company to evaluate, prevent, control, or correct unsafe physical and environmental working condition and hazards.The job responsibilities include:Safety related upgrades/changes with the Manufacturing Engineering group...

  • Environment, Health and Safety Manager

    2 weeks ago

    Hyderabad, India Hammond Power Solutions Full time

    The position is responsible for planning, developing, implementing and directing health and safety programs and activities throughout the Company to evaluate, prevent, control, or correct unsafe physical and environmental working condition and hazards.The job responsibilities include:Safety related upgrades/changes with the Manufacturing Engineering group...

  • Environment, Health and Safety Manager

    2 weeks ago

    Hyderabad, India Hammond Power Solutions Full time

    The position is responsible for planning, developing, implementing and directing health and safety programs and activities throughout the Company to evaluate, prevent, control, or correct unsafe physical and environmental working condition and hazards. The job responsibilities include: Safety related upgrades/changes with the Manufacturing Engineering group...

  • BlackBerry QNX- Senior Functional Safety Engineer/Specialist

    1 week ago

    hyderabad, India QNX Software Systems Full time

    Worker Sub-Type: Regular Job Description:  BlackBerry® QNX® is a trusted supplier of safe and secure operating systems, hypervisors, frameworks and development tools, and provides expert support and services for building the world’s most critical embedded systems. We are the embedded experts. BlackBerry QNX was born in embedded, and provides...

  • BlackBerry QNX- Senior Functional Safety Engineer/Specialist

    2 weeks ago

    Hyderabad, India QNX Software Systems Full time

    Worker Sub-Type:Regular Job Description: BlackBerry® QNX® is a trusted supplier of safe and secure operating systems, hypervisors, frameworks and development tools, and provides expert support and services for building the world’s most critical embedded systems. We are the embedded experts. BlackBerry QNX was born in embedded, and provides time-tested...

  • Specialist, Learning Management Support

    7 days ago

    Hyderabad, India Bristol Myers Squibb Full time

    Description WWPS is responsible for ensuring the safety of our medicines: pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments and ensuring...

  • Specialist, Learning Management Support

    6 days ago

    hyderabad, India Bristol Myers Squibb Full time

    Description WWPS is responsible for ensuring the safety of our medicines: pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, execution of certain post-marketing commitments and ensuring...

  • Procurement Expert

    4 weeks ago

    Hyderabad, India GCC SERVICES Full time

    We're Talent Pooling for an experienced Procurement Officer - Food Specialist to add to our growing team. As our Procurement Officer - Food Specialist, you will be responsible for overseeing and managing the procurement and sourcing of food products for our organization. You will research and evaluate suppliers, negotiate contracts, and ensure that all food...

  • Procurement Expert

    3 weeks ago

    hyderabad, India GCC SERVICES Full time

    We're Talent Pooling for an experienced Procurement Officer - Food Specialist to add to our growing team. As our Procurement Officer - Food Specialist, you will be responsible for overseeing and managing the procurement and sourcing of food products for our organization. You will research and evaluate suppliers, negotiate contracts, and ensure that all...

  • Global Specialist, Solutions Delivery Pipeline

    1 month ago

    hyderabad, India Novartis Full time

    Job Summary/Purpose :The Global Specialist, Solutions Delivery Pipeline & Portfolio Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role is managing service delivery for a business area/sub capability of the company across all geographies. Accountable to Global Business Units for end-to-end project...

  • Whs Officer

    4 weeks ago

    Hyderabad, India ASSPL - Telangana Full time

    3+ years previous experience in Environment, Health & Safety or ME in Industrial Safety Engineering - Bachelor’s degree in engineering or a related field required. - Experience in reputed private or government organizations - Experience managing multiple direct reports. - Must be flexible regarding shifts. - Experience implementing lean principles and...

  • Global Specialist, Business Analyst Regulatory Solutions

    4 weeks ago

    Hyderabad, India Novartis Full time

    Job Summary/Purpose :The Global Specialist, Business Analyst Regulatory Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis. Engage with global business leaders and...

  • Global Specialist, Business Analyst Regulatory Solutions

    1 month ago

    hyderabad, India Novartis Full time

    Job Summary/Purpose :The Global Specialist, Business Analyst Regulatory Solutions reports to the Global Head, Regulatory, Patient Safety and Pipeline & Portfolio Solutions. The role act as an advisor providing guidance to improve global business processes, products, services, and software through data analysis. Engage with global business leaders and...