Talent.com
Safety & PV Specialist II (Literature Review)
Safety & PV Specialist II (Literature Review)Confidential • Hyderabad / Secunderabad, Telangana, India
Safety & PV Specialist II (Literature Review)

Safety & PV Specialist II (Literature Review)

Confidential • Hyderabad / Secunderabad, Telangana, India
16 days ago
Job description

Description

Safety & PV Specialist II (Literature Review)

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.

Job Responsibilities

JOB RESPONSIBILITIES

  • Conduct systematic and ad-hoc literature searches in global biomedical databases (e.g., Embase, PubMed, Medline) for ICSR identification and safety-relevant information.
  • Skilled in extracting and summarizing key safety information from identified literature sources
  • Thorough understanding of creating and validating search strategies for pharmacovigilance purpose.
  • In depth knowledge of major literature databases such as Embase, PubMed etc.
  • Experience in conducting local literature searches and reviews.
  • Understanding of regulatory requirements with respect to global and local literature.
  • Enters information into PVG quality and tracking systems for receipt and tracking ICSR.
  • May assist in the preparation of the Safety Management Plan
  • Processes ICSRs according to Standard Operating Procedures (SOPs) and project / program-specific safety plans.
  • Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability.
  • Enters data into safety database.
  • Codes events, medical history, concomitant medications and tests.
  • Compiles complete narrative summaries.
  • Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved.
  • Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements.
  • Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases.
  • Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports.
  • Participate in audits / inspections as required
  • Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP / Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate.
  • Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug / biologic / device regulations, GCPs, ICH guidelines, GVP, project / program plans and the drug development process.
  • Good communication and interpersonal skills, both written and spoken

    Bachelor's Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.

    What We're Looking For

  • Bachelor's Degree, Postgraduate in health profession with relevant experience, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.
  • At least 3+ years of experience in Pharmacovigilance, Literature case reviewing (Global+Local), Identifying NICR (Signal & AR) report from Literature.
  • Mandatory to have GVP Module 6 knowledge
  • Safety Database systems and knowledge of medical terminology required
  • Good understanding of clinical trial process across Phases II-IV and / or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance
  • Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management / shared content / workspace) and internet.
  • Ability to work independently and in a team environment
  • Good communication and interpersonal skills, both written and spoken
  • Good organizational skills with proven ability to prioritize and work on multiple tasks and projects
  • Detail oriented with a high degree of accuracy and ability to meet deadlines
  • Minimal travel may be required (up to 5%)
  • Get to know Syneos Health

    Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

    No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

    http : / / www.syneoshealth.com

    Additional Information

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

    Summary

    Performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project / program-specific procedures for clinical trials and / or post-marketing safety programs.

    Skills Required

    pubmed, ich gcp , Medical Terminology, Pharmacovigilance, medline , Microsoft Office Suite

    Create a job alert for this search

    Safety Specialist • Hyderabad / Secunderabad, Telangana, India

    Related jobs
    Healthcare Risk and Safety Manager

    Healthcare Risk and Safety Manager

    GBIT (Global Bridge InfoTech Inc) • Hyderabad, Republic Of India, IN
    The Manager of Pharma Mystery / Secret Shopping is responsible for leading compliance testing programs across online pharmaceutical and healthcare platforms. This role ensures compliance with prescr...Show more
    Last updated: 30+ days ago • Promoted
    Product Stewardship Specialist (Plastics & Films)

    Product Stewardship Specialist (Plastics & Films)

    Eastman • Hyderabad, Republic Of India, IN
    The Product Steward is the key link between Eastman’s Advanced Materials segments (Specialty Plastics, Advanced Interlayers, and Performance Films) and the larger Global Product Stewardship & Regul...Show more
    Last updated: 11 days ago • Promoted
    Trainer For Safety Products

    Trainer For Safety Products

    PREVOR • Hyderabad, Republic Of India, IN
    Adviser / Trainer for safety products and chemical risk management.Zone covered : Hyderabad, Télangana.PREVOR, a French laboratory, has been focusing for the past 60 years on researching toxicology ...Show more
    Last updated: 21 days ago • Promoted
    Prod. Steward Rep I - Plastics & Films

    Prod. Steward Rep I - Plastics & Films

    Eastman • Hyderabad, Telangana, India
    The Product Steward is the key link between Eastman’s Advanced Materials segments (Specialty Plastics, Advanced Interlayers, and Performance Films) and the larger Global Product Stewardship & Regul...Show more
    Last updated: 11 days ago • Promoted
    Safety Product Education Specialist

    Safety Product Education Specialist

    PREVOR • Hyderabad, Republic Of India, IN
    Adviser / Trainer for safety products and chemical risk management.Zone covered : Hyderabad, Télangana.PREVOR, a French laboratory, has been focusing for the past 60 years on researching toxicology ...Show more
    Last updated: 9 days ago • Promoted
    Product Compliance Coordinator (Plastics Films)

    Product Compliance Coordinator (Plastics Films)

    Eastman • Hyderabad, Republic Of India, IN
    The Product Steward is the key link between Eastman’s Advanced Materials segments (Specialty Plastics, Advanced Interlayers, and Performance Films) and the larger Global Product Stewardship & Regul...Show more
    Last updated: 11 days ago • Promoted
    Trust and Safety Solutions Leader

    Trust and Safety Solutions Leader

    Genpact • Hyderabad, Republic Of India, IN
    Ready to shape the future of work?.At Genpact, we don’t just adapt to change—we drive it.AI and digital innovation are redefining industries, and we’re leading the charge.Genpact’s AI Gigafactory, ...Show more
    Last updated: 3 days ago • Promoted
    Tech-Functional Business Analyst – Safety Systems (Argus, DLP, Case Processing)

    Tech-Functional Business Analyst – Safety Systems (Argus, DLP, Case Processing)

    vueverse. • Hyderabad, IN
    Senior IT / Tech-Functional Business Analyst.Pharmacovigilance (PV) safety systems, particularly.This role focuses on system configuration, enhancements, integrations, validation, and ongoing technic...Show more
    Last updated: 6 days ago • Promoted
    Health, Safety, and Environmental Systems Manager

    Health, Safety, and Environmental Systems Manager

    Sodexo • Hyderabad, Republic Of India, IN
    Sodexo promotes an inclusive and diverse workplace and encourages applications from individuals of all backgrounds.At Sodexo, we offer 100+ service solutions across diverse sectorscorporates, healt...Show more
    Last updated: 17 days ago • Promoted
    Food Safety and Quality Systems Director

    Food Safety and Quality Systems Director

    Inspire • Hyderabad, Republic Of India, IN
    Inspire Brands is disrupting the restaurant industry through digital transformation and operational efficiencies.The company’s technology hub, Inspire Brands Hyderabad Support Center, India, will l...Show more
    Last updated: 2 days ago • Promoted
    Environment, Health and Safety Manager

    Environment, Health and Safety Manager

    ALKEGEN • secunderabad, telangana, in
    Alkegen brings together two of the world’s leading specialty materials companies to create one new, innovation-driven leader focused on battery technologies, filtration media, and specialty insulat...Show more
    Last updated: 4 hours ago • Promoted • New!
    International Food Safety Specialist

    International Food Safety Specialist

    Inspire • Hyderabad, Republic Of India, IN
    Inspire Brands is disrupting the restaurant industry through digital transformation and operational efficiencies.The company’s technology hub, Inspire Brands Hyderabad Support Center, India, will l...Show more
    Last updated: 2 days ago • Promoted
    Trust & Safety Program Director

    Trust & Safety Program Director

    GBIT (Global Bridge InfoTech Inc) • Hyderabad, Republic Of India, IN
    The SDM(Service Delivery Manager) will oversee all Trust & Safety and Mystery / Secret Shopping programs to ensure compliance for payment card brands including Visa, MasterCard, American Express, a...Show more
    Last updated: 30+ days ago • Promoted
    Sr Safety Specialist (Literature Review)

    Sr Safety Specialist (Literature Review)

    Confidential • Hyderabad / Secunderabad, Telangana, India
    Sr Safety Specialist (Literature Review).Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, med...Show more
    Last updated: 25 days ago • Promoted
    Sr SAP EHS Functional

    Sr SAP EHS Functional

    KATBOTZ® • Hyderabad, IN
    We are seeking a highly skilled.SAP Environment, Health, and Safety (EHS) solutions.The ideal candidate will have deep knowledge of SAP EHS modules, regulatory compliance requirements, and process ...Show more
    Last updated: 22 days ago • Promoted
    Trainer for safety products

    Trainer for safety products

    PREVOR • Hyderabad, Telangana, India
    Adviser / Trainer for safety products and chemical risk management.Zone covered : Hyderabad, Télangana.PREVOR, a French laboratory, has been focusing for the past 60 years on researching toxicology ...Show more
    Last updated: 20 days ago • Promoted
    Assistant Vice President - Trust and Safety ( Service Line)

    Assistant Vice President - Trust and Safety ( Service Line)

    Genpact • Hyderabad, Telangana, India
    Ready to shape the future of work?.At Genpact, we don’t just adapt to change—we drive it.AI and digital innovation are redefining industries, and we’re leading the charge.Genpact’s AI Gigafactory, ...Show more
    Last updated: 3 days ago • Promoted
    Technical Manager - Health, Safety & Environment

    Technical Manager - Health, Safety & Environment

    Sodexo • Hyderabad, Republic Of India, IN
    Sodexo promotes an inclusive and diverse workplace and encourages applications from individuals of all backgrounds.At Sodexo, we offer 100+ service solutions across diverse sectorscorporates, healt...Show more
    Last updated: 17 days ago • Promoted