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 career 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 [email protected] or call at (phone hidden)

📌 Drug Safety Officer (Surat)
🏢 Triple Constraints Consultancy
📍 Surat