Manager - Safety Surveillance & Risk Management

Full Time | Hal Hyderabad, TELANGANA | 4 months | Deadline: 04 Jun 2019
This position has expired. Do not apply!

Job Summary

Full Time
Hal Hyderabad
Mylan

Job Description


Primary Location
 - IND-Telangana-Hyderabad
Organization
 - Mylan Laboratories Limited 
Manager - Safety Surveillance & Risk Management - 19000546 

For Us, It’s A Mission
At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world’s 7 billion people. If you are unconventional, relentless and passionate.  If you believe in doing what’s right, not what’s easy. If you are a doer and have a passion for serving others, we want to talk to you.
 
Make a Difference
At Mylan, each person has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role. Here’s how this role will help:
 
Acting as a Safety Surveillance and Risk Management Team Manager:
  • Aggregate reports
    • Responsible for managing (including scheduling, quality and compliance) Periodic Safety Update Reports (PSUR) and Addendum to Clinical Overview (ACO) related activities (including but not limited to PSUR scheduling, data collection, writing, review, handling of requests received from Central & Local Regulatory Affairs and PV departments) within respect of timelines and any other related task.
    • Responsible for managing Development Safety Update Reports (DSUR) related activities in collaboration with clinical safety team.
  • Risk Management Plan:
    • Liaising with regional and global RA team for scheduling of RMPs
    • Providing safety input
    • Authoring and Reviewing RMPs
    • Assisting and guiding affiliates in implementation of RMMs
  • Signal Management
    • Keep full oversight of signal management activities
    • Provides assistance in the signal management process
    • Authoring signal evaluation reports
    • Conducting safety reviews
  • Reference Safety Information / CCDS:
    • Keep full oversight of RSI/CCDS development, review and updating
    • Maintenance of CCDS
    • Tracking and archiving
    • Training of team members
  • Safety triggers:
    • Regulatory intelligence
    • Detection and review of safety triggers
    • Ensure that all the requested action is completed and TWCC are raised
    • Tracking and archiving
  • Health Authority Responses
    • Assists in preparing or prepares responses to Regulatory Authority questions related to safety issues and conducts medical review
  • Overall responsibility of labelling activity:
    • Review of SPC/PIL for safety information
    • Product information verification
    • Labelling remediation project
    • Tracking and archiving

     
  • Liaise with global, regional and local Regulatory, quality, medical affairs, clinical research, commercial & PV Departments, affiliated companies and Mylan drug safety in performance of the above mentioned tasks.
  • Assists in any other Pharmacovigilance projects, as necessary
  • Provides medical safety expertise and training to other personnel, as necessary
  • Keeps current with professional and pharmacovigilance regulations and knowledge
  • Provides guidance to team members in various aspects of drug safety and any other Mylan personnel
  • Writing & update of Standard Operating Procedures (SOP)
  • Assists or oversees any other project where GPS SST is involved, as deemed necessary

  •  
     

    Make Our Values Your Values

    Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude. People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care. Here are the minimum qualifications and essential functions for this position:

     

    • MBBS / BDS
    • Proficiency in speaking, comprehending, reading and writing English is required / preferred 

     

    Why Mylan?


    If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you. With a workforce of more than 40,000 worldwide, we can make a difference. We encourage you to visit Mylan.com  to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

     

    Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement. All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status. Mylan is an Equal Opportunity Employer, Minorities/Female/Disabled/Veteran. (Recruiter edit final line as appropriate to your country)


     
    Schedule
     - Full-time
    Job Posting
     - Apr 19, 2019, 3:42:10 AM
    Unposting Date
     - Jun 4, 2019, 12:59:00 AM 



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