ProductLife Group is looking for Pharmacovigilance Medical Writer||1-5 years of experienced candidate

ProductLife Group’s mission is to improve human health by delivering regulatory compliance services for the safe and effective use of medical solutions. Since almost 30 years, PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 130 countries. It provides consulting and outsourcing services in the areas of regulatory affairs, quality and compliance, vigilances and medical information, covering both established products and innovative therapeutics & diagnostics.

ProductLife Group is looking for Pharmacovigilance Medical Writer to join our dynamic team.

*Roles and Responsibilities:
-Preparation of Risk Management Plan (RMP)
-Preparation of Periodic safety update reports (PSUR / PBRER)
-Preparation of Addendum to the Clinical Overview (ACO)
-Preparation of Periodic Adverse Drug Experience Report (PADER)
-Preparation of Development Safety Update Report (DSUR)
-Preparation of Signal Report
-Provide support in audits and inspections
-Prepare the documents as per SOPs & WIs

Qualification: BPharm / MPharm / MSc

Experience:
1-5 years of experienced candidate in RMP, PSUR, ACO, PADER, DSUR, Signal

*Knowledge and Skills:
-Excellent oral/written communication in English
-Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word

Thank you!