Email Address Password  
Remember Login Forgot Password?
Share:

Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses, Drug Safety Reports , review of published literature and case listings; Vigilance over important/designated medical events;
Interaction with client personnel to discuss potential signals and issues detected with products; Support preparation and maintenance of Risk Management Plans;
Follow-up and interaction with clients to obtain incomplete/missing information, with a view to resolving and clarifying issues;
Performing medical review of individual case safety reports (ICSRs); Performing medical review of narratives for Clinical Study Reports (CSRs);


Providing medical advice to drug safety scientists to assist them with processing of ICSRs and CSR narratives;
Maintaining an excellent knowledge of the adverse event safety profile of assigned drugs, labelling documents, and client guidelines and Standard Operating Procedures (SOPs);


Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for report submissions;


Maintaining records in compliance with guidelines and SOPs







UG: MBBS - Medicine

PG:Post Graduation Not Required, M.S/M.D - Any Specialization

Doctorate: Doctorate Not Required

**Ayurvedic, homeopathic, veterinary doctors or from other alternative medical streams and scientists with life sciences background need not apply for this position; A degree in Medicine (MBBS) or a post-graduation qualification (MD) is desired .

Fluency in written and spoken English is must




we need MBBS/MD physicians who can commit to work for at least 2 years and they should preferably be from North India. >

Drug Safety Physician(md,mbbs)

Designation / Job Role : Other
Job Description :
Report preparation [e.g. Periodic Safety Update Reports (PSURs), Addendum PSURs, Bridging Reports, PSUR Line Listings, US PADERs] from aggregate data for products, in accordance with client conventions and requirements;

Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses, Drug Safety Reports , review of published literature and case listings; Vigilance over important/designated medical events;
Interaction with client personnel to discuss potential signals and issues detected with products; Support preparation and maintenance of Risk Management Plans;
Follow-up and interaction with clients to obtain incomplete/missing information, with a view to resolving and clarifying issues;
Performing medical review of individual case safety reports (ICSRs); Performing medical review of narratives for Clinical Study Reports (CSRs);


Providing medical advice to drug safety scientists to assist them with processing of ICSRs and CSR narratives;
Maintaining an excellent knowledge of the adverse event safety profile of assigned drugs, labelling documents, and client guidelines and Standard Operating Procedures (SOPs);


Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for report submissions;


Maintaining records in compliance with guidelines and SOPs







UG: MBBS - Medicine

PG:Post Graduation Not Required, M.S/M.D - Any Specialization

Doctorate: Doctorate Not Required

**Ayurvedic, homeopathic, veterinary doctors or from other alternative medical streams and scientists with life sciences background need not apply for this position; A degree in Medicine (MBBS) or a post-graduation qualification (MD) is desired .

Fluency in written and spoken English is must




we need MBBS/MD physicians who can commit to work for at least 2 years and they should preferably be from North India.
Speciality : Other
Number of Openings : 1
Hiring For : Client Of Kelly services
Location(s) : Chandigarh
Country : India
Experience : 0 - 5 year(s)
Salary : Not Specified
Salary Remarks : Not Disclosed by Recruiter
Date Posted : 31-Dec-2014
Application Deadline : Not Specified
Requirements
Education : MBBS- Medicine
M.S/M.D - Any Specialization
Any Doctorate - Any Specialization, Doctorate Not Required
Candidate Profile : Please refer to the Job description above
Company Profile
Posted By : Mr. DocLynk Admin
Organisation Name : Medigrity
Designation : Administration
Job Reference : Not Specified
 
 
   

Physician Sign up (free)

   
First Name
Last Name
Email
Password
I accept the Privacy Policy and Terms & Conditions of DocLynk

Non-Physicians ?

Sign up Here