Responsible for the drug surveillance program including the necessary follow-up, risk assessment, and relatedness to product on adverse reaction reports, oversight of safety in clinical trials and post marketing programs.
Hands-on experience in Bag Filling Machine, preferably SHINVA Bag Filling / PLUMAT. Handling complex manufacturing processes such as Emulsion and Suspension.
Operate and monitor granulation, blending and compression machines. Ensure optimal machine performance and adherence to batch manufacturing records. Cronus Pharma
Review of complaints related to ExM which are received for various suppliers. Review the adequacy of investigations and coordinate with internal and external stake holders for closure.
Handle inbound and outbound calls related to healthcare services. Provide excellent customer service by addressing queries, concerns and complaints professionally.
Develop and execute regulatory strategies, providing leadership and guidance on pharmaceutical regulatory requirements across India and South Asia to support product registrations, market access, launches, lifecycle management, and post-market compliance.