Job Purpose: The QPPV shall be responsible for the establishment and maintenance of the marketing authorization holder’s pharmacovigilance system and therefore shall have sufficient authority to influence the performance of the quality system and the pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements.
Key Accountabilities:
1.Establish and maintain Cipla’s PV system(s) in Brazil as per the regulatory guidelines.
2.Lead, drive, track and monitor entire PV systems at Brazil to ensure no non-compliances
* Overview of medicinal product/medical device’s safety profiles and any emerging safety concerns
* Develop and Implement SOP for PV Activities. Have awareness of any conditions or obligations adopted as part of the marketing authorizations and other commitments relating to safety or the safe use of the products
* Aware of and having sufficient authority over the content of risk management plans
* Ensuring conduct of pharmacovigilance and submission of all pharmacovigilance-related documents in accordance with the legal requirements and GVP
* Ensuring the necessary quality, including the correctness and completeness, of pharmacovigilance data submitted to the competent authorities
3.Co-ordinate with Regulatory authorities in Brazil as a SPOC for Brazilian Agencies as strong liaison for PV compliances
* Act as a SPOC for pharmacovigilance contact point for the competent authorities in Brazil State and the Agency on a 24-hour basis and as a contact point for pharmacovigilance inspections
* Ensure a full and prompt response to any request from the competent authorities and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product
* Provide any other information relevant to the benefit-risk evaluation to the competent authorities in Brazil and the Agency
* Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals)
4.Co-ordinate with Liaise and serves as SPOC of contact for PV and compliance questions, issues and product recalls
* Ensure all applicable Corporate and Compliance Policies, procedures and requirements are implemented and specific local requirements are met
* Plan, drive and track all affected employees for necessary guidelines/SOP trainings and verifying efficiency from time to time
Educational qualifications:
A licensed pharmacist, biologist or chemist (or a person with another permitted academic qualification) with 2-4 years of experience
Relevant experience:
Must have experience of working in larger pharmaceutical companies in Pharmacovigilance setups. Must be certified, trained and acquainted with PV regulations related and Brazil Pharmaceutical directives.