About the Company
Optimus pharma laid its foundation in 1994, with fully integrated facility in the treatment of “Addiction and pain management”, with OST (opioid substitutional treatment). The company supply the medicines globally including but not limited to Europe, South Africa. Nepal, UK, Russia, Myanmar. Major contributor in supplying to the organizations like NACO, Global fund and ministries, UNOPS, UNODC of various emerging markets. This has formulation facility located in kandla unit and transdermal; patch facility and formulation facility in Dehradun and API facility in Ankaleshwar Gujarat, with various accreditations like EDQM-Spain, WHO (India), state GMP.
The Firm has a core values of respecting people, prioritizing quality, providing better customer support, research driven medicines and continuous improvising, integrity with high standards of ethical values. There is a state of art Research and development labs inaugurated in 2016, with 25 years of rich experience in pharmaceutical development & manufacturing, bringing the innovative technological medicines at an affordable price.
Apart from the pain management, the company has focused on other products like OTC and herbal type delivering products like nicotine gums, acidity relievers, immune improvising.
About the Job
Performing the Initiation, Negotiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice and Preparation of clinical and non-clinical dossier for domestic submissions
Reviewing the phase III CT Protocol/BE study protocol and related documents and required to have Experience in handling bioequivalence studies
Preparing therapeutic rationales for the proposed products in therapeutic areas like derma, cardio, diabetic, neuro etc.,
Experience in preparing slides & participation in SEC meetings to obtain respective approvals
Experience in preparing the justification for bioequivalence waiver documents inline with NDACT rules, 2019.
Required to handle and Perform Contract research Organization selection for Clinical Trials (phase III or PMS) or Bioequivalence studies.
Training on Medical slides to sales and business development team and needed to Provide the Scientific updates on Guidelines
Collaborating with the Pharmacovigilance service vendor to ensure timely response of all the medical information queries, team for providing the status update regarding closure of medical information queries
Strong preparing PSUR periodic submissions as per DCGI approvals and KOL/experts engagement
Handling customer queries related to medical/PV system.
Preparation of scientific medico-marketing initiatives such new product launch slide, Training slide
Supporting regulatory team for domestic and international dossier submissions.
Scientific Literature search - Collating relevant medical information and analysing it for medico -marketing value.
Experience of conducting Webinar, webcast, medical symposium be a local safety officer for OPPL.
Support the Pharmacovigilance, Responsible for maintaining the Medical Information query