24 Oct
|
Mega We Care
|
Thane
24 Oct
Mega We Care
Thane
Are you a highly responsible person? : Do you have a knack of knowing what’s important? : Do you have a knack of knowing how to partner with people? : Mega Lifesciences is looking for an Executive - Pharmacovigilance to work closely with Assistant Manager - Pharmacovigilance in a rapid-paced environment that will offer ample opportunities to learn and expand your experience and expertise.
Job Summary : As an Executive/Sr. Executive - Pharmacovigilance , your key tasks are as below:
- Authoring aggregate safety reports including PSURs, PBRERs, RMPs, and AddCos
- Performing data entry and management of ICSRs in the global safety database
- Conducting literature searches for individual and periodic safety reports
- Ensuring compliance with internal SOPs and global regulatory requirements
- Coordinating with global pharmacovigilance affiliates
Qualification & Experience :
- Bachelor’s Degree or Master’s Degree in Pharmacy
- Minimum 2 - 4 years of experience in pharmacovigilance, with a strong focus on authoring aggregate reports (PSUR, PBRER, RMP, AddCo)
- Hands-on experience in ICSR case processing, literature review, safety signal identification
- Familiarity with regulatory requirements and compliance standards (ICH, GVP, FDA, EMA, local PV regulations)
Skill & Knowledge : For any further clarification and information related to the position, you may please contact +91 22 4141 7923 (Ms. Pradnya).
📌 Executive - Pharmacovigilance (Thane)
🏢 Mega We Care
📍 Thane