Biological E Limited Hiring For QA Pharmacovigilance 

Biological E Limited Hiring For QA Pharmacovigilance 

Biological E Limited Job Vacancy Details: 

Biological E. Limited is hiring for QA Pharmacovigilance, Pharma SGI - USFDA Approved plant, Shamirpet location, Hyderabad.

Position: Executive/ Senior Executive

Qualification: B.Pharmacy/ M.Pharmacy

Experience: 4 to 9 years

Job Description:

* Responsible to monitor the pharmacovigilance activities as per the SOPs.

* To coordinate with the third party pharmacovigilance services to obtain the Medical Information Call Center(MICC) reports, Medical literature monitoring(MLM) reports, Individual Case Safety Reports(CSR) and Drafts Periodic Adverse Drug Event Reports(PADER).

* Responsible for Preparation, Review and maintain the Safety Data Exchange Agreements(SDEA).

* Responsible for Review of Individual Case Safety Reports ICSR).

* To ensure that all the Pharmacovigilance activities were completed and reported in
timely manner.

* Responsible to Review and maintain the Medical literature monitoring(MLM) schedule and Periodic Adverse Drug Event Reports(PADER) calendar.

* Responsible for Handling of market complaints, Investigations and Proposing appropriate CAPAS Accordingly.

* Preparation and review of Standard Operating Procedures (SOP).

* Responsible for the preparation of market complaints Trends as per the SOP requirements.

* Preparation of ADE summary reports as applicable (Adverse Event).

*Responsible for initiation of Change Controls, Deviations and CAPAS.

How To Apply For Biological E Limited Job 

Interested aspirants with relevant skills set can share their resumes to Mahesh.Patsamatla@biologicale.com