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The Sr. Pharmacovigilance Physician (Sr. PVP) has additional responsibility to those of the Pharmacovigilance Physician in that the incumbent is expected to play a greater role as a senior technical leader and participate more fully in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts. This will be demonstrated by preparing sections of aggregate safety reports such as PSURs, ad-hoc regulatory reports, Risk Management Plans etc. Interpretation of surveillance and product quality data.

In addition, the Senior Pharmacovigilance Physician will work in conjunction with the Safety Surveillance Group and be responsible for surveillance activities for selected products.



RESPONSIBILITIES

Medical evaluation of individual adverse event case safety reports, including but not limited to all serious and expedited reports and all pregnancy reports.

Accountable for review and interpretation, analysis and summarization of aggregate safety data from all sources including spontaneous, clinical, post-marketing and observational studies, literature review and product quality, (e.g. RMP, PSUR, ad-hoc regulatory reports, etc)

Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing a Pharmacovigilance Physician product team and/or technical leadership in single case assessment.

Participate in signal detection efforts, e.g. strategy meetings for PSURs and periodic reports and structured surveillance programs and execution of pharmacovigilance components of Risk Management Programs and related activities including assessment of potential signals

Lead or participate as members of pharmacovigilance matrix-teams responsible for pharmacovigilance activities focused on individual products and therapeutic areas.

Responsibilities include training activities, participation in selected reviews of aggregate reports such as PSURs, PADERS, contributing to the development and implementation of risk minimization action plans, etc.



REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Sound knowledge of Medicine

In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical

Practice (GCP) and International Conference on Harmonisation (ICH) guidelines

Knowledge of Pharmacovigilance- ICSR & Aggregate reports

In-depth knowledge of departmental standard operating procedures (SOPs)

Skill in use of multiple safety databases

Adequate Computer skills, especially Microsoft word, excel & PowerPoint.

Good communication skills- verbal & written

Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients

and regulatory agency representatives

Ability to establish and maintain effective working relationships with coworkers, managers and clients >

Pharmacovigilance Physician

Designation / Job Role : Regulatory Affairs Manager
Job Description :
The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall BRM pharmacovigilance process.
The Sr. Pharmacovigilance Physician (Sr. PVP) has additional responsibility to those of the Pharmacovigilance Physician in that the incumbent is expected to play a greater role as a senior technical leader and participate more fully in matrix management activities including preparation or participation in evaluating safety issues and preparation of aggregate reports in collaboration with the Post-Marketing Safety Experts. This will be demonstrated by preparing sections of aggregate safety reports such as PSURs, ad-hoc regulatory reports, Risk Management Plans etc. Interpretation of surveillance and product quality data.

In addition, the Senior Pharmacovigilance Physician will work in conjunction with the Safety Surveillance Group and be responsible for surveillance activities for selected products.



RESPONSIBILITIES

Medical evaluation of individual adverse event case safety reports, including but not limited to all serious and expedited reports and all pregnancy reports.

Accountable for review and interpretation, analysis and summarization of aggregate safety data from all sources including spontaneous, clinical, post-marketing and observational studies, literature review and product quality, (e.g. RMP, PSUR, ad-hoc regulatory reports, etc)

Provide therapeutic area/pharmacovigilance issue guidance in the context of leading/managing a Pharmacovigilance Physician product team and/or technical leadership in single case assessment.

Participate in signal detection efforts, e.g. strategy meetings for PSURs and periodic reports and structured surveillance programs and execution of pharmacovigilance components of Risk Management Programs and related activities including assessment of potential signals

Lead or participate as members of pharmacovigilance matrix-teams responsible for pharmacovigilance activities focused on individual products and therapeutic areas.

Responsibilities include training activities, participation in selected reviews of aggregate reports such as PSURs, PADERS, contributing to the development and implementation of risk minimization action plans, etc.



REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Sound knowledge of Medicine

In-depth knowledge of applicable global, regional and local clinical research regulatory requirements; i.e., Good Clinical

Practice (GCP) and International Conference on Harmonisation (ICH) guidelines

Knowledge of Pharmacovigilance- ICSR & Aggregate reports

In-depth knowledge of departmental standard operating procedures (SOPs)

Skill in use of multiple safety databases

Adequate Computer skills, especially Microsoft word, excel & PowerPoint.

Good communication skills- verbal & written

Ability to establish and maintain effective working relationships with managers, co-workers, investigative site staff, clients

and regulatory agency representatives

Ability to establish and maintain effective working relationships with coworkers, managers and clients
Speciality : Other
Number of Openings : 1
Hiring For : Not Disclosed
Location(s) : Bengaluru/Bangalore
Country : India
Experience : 0 - 5 year(s)
Salary : Not Specified
Salary Remarks : Not Disclosed by Recruiter
Date Posted : 06-Jan-2015
Application Deadline : Not Specified
Requirements
Education : MBBS- Medicine
M.S/M.D - Any Specialization, Other
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
 
 
   

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