Periodic Safety and Risk Management - Lead Executive
Periodic Safety and Risk Management - Lead Executive
Apotex
Job description
Apotex is hiring a Lead Executive for Periodic Safety and Risk Management in Mumbai, offering a great career opportunity for physicians, Pharm.D., and M.Pharm professionals in global pharmacovigilance.
Company Description
Apotex is a company that works globally to make medicine and health products more accessible and affordable for people around the world. It helps millions of people every day by offering a range of treatments. The company produces drugs, biosimilars, branded medicines, and consumer health products. Apotex has its office in Toronto. It also has offices in the United States, Mexico, and India. It is a pharmaceutical company based in Canada.
Job Summary
This role is for a Lead Executive in Periodic Safety and Risk Management within global pharmacovigilance, based in Mumbai. The person will prepare and review periodic safety reports under drug safety rules and ICH guidelines. The role also includes reviewing events, checking causality, and supporting new product development teams.
Key Responsibilities
Prepare and peer review periodic safety update reports, such as PSURs, PBRERs, and PADERs, for regulatory submission.
Keep up to date on safety issues for Apotex products through ongoing monitoring and literature review.
Study and explain safety data using strong scientific skills.
Write replies to more complex questions and requests for safety information from internal teams such as RA, QA, and product development.
Use sound medical judgment to review adverse reports and solve causality questions with reporting sites.
Take part in global new product development project teams and support product life cycle work.
Write and update SOPs.
Create and maintain training documents and track compliance of global partners involved in drug safety reporting.
Keep working on knowledge of Oracle Argus and MedDRA.
Follow ICH guidelines, company rules, and all pharmacovigilance regulations.
Educational Qualification
A degree in medicine, Pharm.D., M.Pharm, nursing, or a related health science field is required.
Candidates must have 3 to 5 years of core pharmacovigilance experience in the industry.
Skills Required
Knowledge of MedDRA, Oracle ARGUS, and online literature searching is preferred.
Strong knowledge of drug safety rules and international drug safety rules. Also familiar with ICH guidelines.
Proficient in Microsoft Excel, PowerPoint, and Word.
Experience of 1 to 2 years in periodic reviews of aggregate safety data is preferred.
Salary Structure
The salary for a Lead Executive - PSRM / Patient Safety and Risk Management at Apotex Research in India typically ranges from ₹10.3 Lakhs to ₹13 Lakhs per year.
Career Development
This role builds skills in aggregate safety reporting and risk management within a global pharma company. It can help you move toward pharmacovigilance scientist or safety team lead positions over time.
How to Apply
Visit our job portal and search for the Lead Executive PSRM role at Apotex.
Click on the job posting to see all the details about the job.
Enter your information and add your resume.
Send your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
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Hiring Trends
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