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Senior Medical Manager – PSS

ManagerManagerFull TimeRemoteSeniorTeam 10,001+H1B No SponsorCompany SiteLinkedIn

Location

India

Posted

96 days ago

Salary

0

Seniority

Senior

Postgraduate Degree5 yrs expEnglish

Job Description

Senior Medical Manager – PSS

Fortrea

• Responsible for medical review of serious adverse events and adverse events of special interest from clinical trials in support of drug safety activities for clients. • Responsible for preparation and medical review of Aggregate Reports required by global regulatory agencies for review of safety information. • Responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues. • Participates in training opportunities to advance knowledge of pharmacovigilance as it relates to drug/product development and marketing. • Provides medical/safety expertise to project teams and communicates information regarding drug safety regulations. • Assists in the preparation of pharmacovigilance materials for investigator meetings. • Participates in project risk assessment activities and assumes responsibility for medical and safety monitoring on assigned projects.

Job Requirements

  • MBBS and/or MD with at least 2 years of clinical medicine experience.
  • Experience in Oncology therapy area (Clinical Trial or Post marketing PV) is a must have.
  • MD who has completed an accredited residency program or equivalent and is board-eligible or certified with at least 5 years’ experience, with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and patient safety.
  • At least 5 years of experience working either for a pharmaceutical company, health authority or a contract research organization in pharmacovigilance or patient safety.

Benefits

  • Remote-Based, as requested by the line manager.
  • Work Timings: 2 PM - 11PM IST.

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