Mitocon Biopharma Pvt Ltd Hiring For Drug Safety Physician

Responsibilities

• Perform comprehensive medical assessment of individual adverse event cases, evaluating seriousness, expectedness, and causality.
• Determine regulatory reportability criteria and ensure timely preparation and submission of expedited safety reports (e.g., SUSARs) to health authorities.
• Review patient medical records, vital signs, laboratory results, and narrative summaries to assess clinical relevance.
• Conduct thorough literature review to support causality assessment and expectedness determination.
• Identify, resolve, and appropriately escalate complex case issues to Medical Managers and cross‑functional teams.
• Maintain up‑to‑date knowledge of product safety profiles, therapeutic areas, and emerging safety signals.
• Contribute to the preparation of aggregate safety reports such as PADER, PSUR, DSUR, RMP, and signal detection reports.
• Support the development and review of safety narratives for periodic safety update reports.
• Participate in signal detection activities using global safety databases and risk management tools.
• Collaborate with pharmacovigilance data management, biostatistics, and regulatory affairs to ensure data integrity.
• Provide medical input for risk management plans and risk minimization strategies.
• Assist in the preparation of audit‑ready documentation and respond to regulatory inspection queries.
• Support quality assurance activities, including internal audits, SOP compliance checks, and training of junior staff.
• Contribute to study close‑out activities, ensuring final safety data are accurately captured and reported.
• Liaise with external investigators, CROs, and health‑care professionals to obtain additional clinical information when required.
• Review and approve safety‑related sections of clinical trial protocols and informed consent forms.
• Participate in cross‑functional safety review meetings and present medical assessments to senior leadership.
• Ensure all case processing activities comply with GCP, ICH E2D, and local regulatory guidelines.
• Document all medical assessments, decisions, and rationale in the safety database with appropriate traceability.
• Provide mentorship and training to new pharmacovigilance associates on case assessment methodology.
• Support the development of standard operating procedures (SOPs) for medical safety assessment.
• Conduct root‑cause analysis for recurring safety issues and propose corrective actions.
• Monitor and evaluate the impact of safety signals on product labeling and risk communication.
• Assist in preparing safety sections for regulatory submissions such as NDAs, MAAs, and post‑marketing commitments.
• Participate in internal and external safety webinars, conferences, and continuous learning programs to stay current with industry trends.

Skills

• Medical case assessment
• Causality determination (WHO‑UMC, Naranjo)
• Regulatory reporting (e.g., SUSAR, CIOMS)
• Knowledge of ICH E2D, E2E, E2F guidelines
• Pharmacovigilance database systems (e.g., Argus, Arisg, Veeva)
• Clinical data interpretation
• GCP and Good Pharmacovigilance Practices (GPvP)
• Signal detection and risk management
• Preparation of PADER, PSUR, DSUR, RMP
• Medical writing and narrative development
• Strong understanding of therapeutic area (oral health)
• Excellent communication and stakeholder management
• Attention to detail and analytical thinking
• Ability to work under tight deadlines
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Knowledge of local regulatory requirements (CDSCO, DCGI)
• Experience with audit and inspection readiness
• Team collaboration and cross‑functional coordination
• Training and mentorship capabilities
• Problem‑solving and escalation management
• Data privacy and confidentiality compliance
• Ability to interpret laboratory and vital sign data
• Familiarity with electronic safety reporting tools
• Critical thinking for signal evaluation
• Time management and prioritization
• Knowledge of medical terminology and drug classifications
• Ability to draft safety sections for regulatory submissions
• Understanding of risk minimization strategies
• Experience with adverse event follow‑up
• Continuous learning mindset

Company Overview

Mitocon Biopharma Pvt Ltd is a fast‑growing pharmaceutical company headquartered in Hyderabad, specializing in innovative oral health solutions and specialty therapeutics. The company’s portfolio includes patented dental care products, generic formulations, and pipeline molecules targeting chronic oral diseases. With a strong presence across Indian retail chains, hospital pharmacies, and export markets in the Middle East and Africa, Mitocon Biopharma is recognized for its commitment to scientific excellence, regulatory compliance, and patient safety. The organization offers robust career growth pathways, continuous learning programs, and exposure to global pharmacovigilance standards, making it an attractive employer for professionals seeking to advance in the life‑sciences industry.

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