Thane

Lead Commissioning, Qualification & Validation activities for equipment, utilities, and computerized systems. Develop & approve IQ, OQ, PQ, cleaning validation, process validation, and CPV documentation.

Post-graduate in Life Sciences (preferably Pharmacy) with minimum of 3 years pharmaceutical industry experience in regulatory affairs with proven track record and experience in health authority interactions and negotiations, end-to-end regulatory submissions

Degree in Pharmaceutical Manufacturing B.Pharmacy from an institution recognized by the Pharmacy Council.

To have an oversight on CRO partners for outsourced studies by conducting oversight quality visits at sites if applicable, conduct regular meetings and seek regular updates on study progress.

Promote pharma product portfolio to healthcare professionals and institutions. Develop and maintain strong relationships with doctors, pharmacists, and key opinion leaders.

Perform monitoring and site management work to ensure that sites are conducting the studyies and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Review all activities promoted or induced by Bayer Mumbai CH Division that directly or indirectly involve exposure of a human being to any pharmaceutical & OTC products. Make sure that all promotional activities are made in accordance with local Regulations.

Masters degree in Life Sciences or equivalence scientific degree with minimum of 5-7 years pharmaceutical industry experience in regulatory affairs with at least 2 years of proven leadership, technical specialist role experience in health authority interactions

The Regional PV Officer contributes to assure patients safety by complying with all PV Quality System Documents, QSDs and local and international regulatory requirements. The main purpose of the position is to ensure that Bayer Pharmacovigilance standards are met