Executive - Medical Affairs

Job Description:

• Pharmacovigilance of small molecule products.
  • Preparation and submission of PSUR & RMP to DCGI office in stipulated time.
  • Maintaining Calendar of PSUR & keeping track of upcoming PSURs.
  • Preparation and submission of replies related to PSUR queries to DCGI Office.
• Apprise the regulatory team on regulatory updates (New Guidelines/Gazettes/SEC MoMs/Notices/New approvals/CT NOC etc) laid down by CDSCO from implication point of view.
• Providing regulatory status (e.g. worldwide approval status, CTRI status, available strengths and dosage forms, new indications, combination categorization etc.) and literature related to new/existing products as per the requirement.
• Support in dossier preparation and submission for various types of DCG(I) applications for:
  • Manufacturing and Marketing applications for API & finished formulation.
  • Clinical Trial NOC.
  • Bioequivalence study NOC.
  • Query response in stipulated timelines.
• Assisting in preparation for SEC presentation i.e., executive summary, presentation slides, literature set to support presentation.
• Review International dossier related documents.

Desired Qualification/Skillset/Experience:

• Pharmacy Postgraduate (M. Pharm)/Medical Graduate with minimum 3 Years experience.
• Sound knowledge of Pharmacovigilance and Regulatory Affairs as per the prevailing guidelines.
• Quick learner & Excellent team worker with strong organizational, cross-functional working, written and communication skills.
• Self-motivated, hard-working and goal-oriented, ability to function in time-bound manner with high degree of flexibility, creativity, resourcefulness, commitment and optimism.

Competencies:

Job Location & Department:

Department : Medical Affairs.

Job Location : Ahmedabad, Gujarat, India.

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