Pharmacovigilance Services Analyst

3 - 5 years

3 - 7 Lacs

Posted:8 hours ago| Platform: Naukri logo

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Job Type

Full Time

Job Description


 About The Role  

Skill required:
Pharmacovigilance services - Safety Writing

Designation:
Pharmacovigilance Services Analyst

Qualifications:
Bachelor of Pharmacy

Years of Experience:
3-5 Yrs

What would you do?
You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life ¢- enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.

What are we looking for?
Ability to establish strong client relationship

Roles and Responsibilities:
Prepare and review Aggregate reports and any adhoc reports requested by Client.o Conduct or attend and contribute, as applicable, to a kick-off meeting and regular teleconferences with the Client during the preparation of Aggregate reports.o Complete all the sections of Aggregate Reports as per Client SOPs and guidelines and as agreed during kick-off meeting.o Liaise with relevant internal and Client stakeholders for the inputs required for the Aggregate Reports.
  • o Coordinate data cleaning process (missing data clearance and send request for stop/ resume book in of cases) prior to final listings generation.o Perform activities as lead author and prepare submission ready draft for Aggregate reports.o Perform QC of the assigned draft Aggregate reports, per scorecard agreed with Client, and provide feedback to the responsible author with the duly filled scorecard defect tracker.o Review source documentation provided by Client for completeness and accuracy.o Facilitate stakeholders review as defined by the Client.o Shall address all the comments received from all the stakeholders including review comments and provide the respective final versions of the reports to the Client ready for publishing.o On-time escalation of any delayed inputs.
     Qualification Bachelor of Pharmacy
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