Hiring Medical Writer For CRO.

View: 106

Update day: 06-05-2024

Location: Hyderabad / Secunderabad Telangana Bengaluru / Bangalore Karnataka

Category: Pharmaceutical / Chemical / Biotech Health / Medical Care Pharmacist / Pharmaceutical representatives

Industry: Pharmaceutical & Life Sciences

Position: Documentation/Medical Writing

Job type: Full Time, Permanent

Salary: ₹ 8,00,000 - 12,00,000 P.A.

Experience: 2 - 7 years

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Job content

Roles and Responsibilities

Job Purpose:

Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United States Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs), Annual Risk-Benefit Evaluation (ARBE) report, Risk Management Plan (RMP), Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs) as well as preparing document of comparison between local and global labeling document (if applicable) and checking of International Non-proprietary names (INNs) for inclusion in a PSR as per client requirements and signal detection and management (where applicable).
Generating Line Listings, creating drug lists/drug folders, performing regulatory submissions, tests electronic submissions gateways, and tracking compliance monitoring of submissions in accordance with client/international conventions
Responsible for preparing the narratives associated with the clients/sponsors products from clinical trials for Clinical Study Reports (CSRs) or in order to support any health authority requests in accordance with regulatory and clients/sponsors requirements.

Desired Candidate Profile

Knowledge and Experience:

Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.
Good knowledge of medical terminologies

Education:

Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage

Perks and Benefits

8-12 LPA.

Location not constraint- WFH

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