Drug Safety Officer
Company: Triple Constraints Consultancy
- Location: Surat, India
- Seniority: Entry level
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
Pharmacovigilance officer /Drug safety officer
General responsibilities:
Ensuring the conditions of the Wholesale Distribution Authorization are met and that all medicinal products are handled, are received, stored and transported
under strict GxP conditions;
Managing continued professional development (CPD) and training records;
Providing leadership for the regulatory team and developing and implementing operational plans; Taking responsibility for the planning and developing courses of action, including responsibility for the work of others; Regularly reviewing the current procedures to ensure an effective business model is in place and compliance with GxP is constantly upheld;
GxP responsibilities:
Ensuring that quality risk management is implemented throughout Company’s operations ;
Ensuring all employees are sufficiently trained in GxP, their own duties, product identification, the risks of falsified medicines and specific training for products
requiring strict handling;
Ensuring training programs are implemented prior to each employee’s start date and ongoing training is done as required;
Ensuring that the safety and security of all medicinal products is maintained, including product integrity and product storage;
Ensuring storage areas within the warehouse are adequately temperature mapped, qualified and validated; Approving all new and revised documents on eQMS;
Ensuring that all medicinal products are procured from approved suppliers and supplied to approved customers on Sage; Ensuring all imports of unlicensed medicinal products are in compliance with the UK TSE Regulations;
Ensuring a bonded warehouse is utilized for all medicinal products procured from outside of the EEA that are not imported under Company’s MS license;
Monitoring all high-risk products and any unusual sales patterns with regular meetings with the management team;
Reviewing CAPAs and closing out once all actions are complete;
Ensuring that the Regulating Authority (MHRA) and MAH are notified of all suspected falsified medicines;
Responsible for the final disposition of all recall products;
Urgent requirement Pharmacovigilance officer /Drug safety officer
Job Time:
01 PM to 10:30 PM (From April to October)
2:00 PM to 11:30 PM (November to March)
Education:
M.PHARM/B.PHARM/ PHARMA D/ BACHELOR OF SCIENCE DEGREE IN ANY DISCIPLINE
Location : Surat
interested candidate can apply at indeerasingh@thetcscon.com or call at 9833208193
