Pharmacovigilance Manager

Role & responsibilities

Educational Qualification:

M.B.B.S

Experience of the Employee:

16 Years

Job Responsibilities:

Vaccine Safety Physician and Deputy QPPV/PvOIC.

Assessments of reported Adverse events seriousness assessment, expectedness and causality assessment.

Responding to Medical queries from Consumers and Health care professionals.

Review of Periodic safety update reports

Review of Risk Management Plan.

Clinical Investigation of Serious Adverse Event(s) and preparation of Individual Case Safety Report (ICSR).

Development of training module on Pharmacovigilance and training of personnel whenever required.

Review of the ‘Summary of Product Characteristics’ (SmPC), and ‘Prescribing Information’ in case of new products and Assessment for detection of new safety signal for existing products.

Clinical trials: Preparation of Investigator’s Brochure and Safety Reporting Plan, Review of Protocol and, Intimation to regulatory authorities, investigation and assessment of Serious Adverse Events, if any, preparation of ICSR (Individual Case Safety Report) and submission to regulatory authorities in stipulated period. Assessment of adverse events reported in clinical trials.

Carryout responsibilities of QPPV/PVOIC in his/her absence

Carryout responsibilities as Bio safety officer

Authorities:

Deputy QPPV/PVOIC

Responsible authorized person in the employee absence:

QPPV/PVOIC , Medical Services

Chief Manager , Medical Services

Preferred candidate profile