Drug Safety Physician

Biocon Biologics; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

A global biopharmaceutical company is seeking a Drug Safety Physician to oversee safety evaluations and risk management initiatives. The role requires at least 7 years of pharmacovigilance experience and strong leadership skills. Candidates must have an MBBS, PhD, or MD, and be adept at collaborating with stakeholders to ensure compliance and safety management. This is a full-time position based in Bengaluru, India, suitable for individuals looking to make an impact in the pharmaceutical industry.

Qualifications

• 7+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care, or academia.
• Knowledge of biopharmaceutical industry regulations for pharmacovigilance.
• Ability to influence decision-making and collaborate effectively.

Responsibilities

• Evaluate safety data and manage risk to patients.
• Collaborate with functional groups for trend analysis.
• Lead process improvement initiatives in pharmacovigilance.

Skills

Pharmacovigilance experience

Strong communication skills

Leadership

Organizational skills

Education

MBBS/PhD/MD

Tools

MS Office (Excel, PowerPoint, Word)

Job description

Job Overview

Drug Safety Physician at Biocon Biologics. Independently or with senior physicians, responsible for continuous evaluation of the safety profile of company products through adverse event monitoring, supporting clinical trial PV safety activities, overseeing aggregate report reviews, safety signal and risk management activities, and driving proactive implementation of risk management initiatives to meet global regulatory requirements. The candidate should demonstrate leadership, strong communication, and the ability to oversee CRO activities and influence external and internal stakeholders. The role serves as a subject matter expert for product-specific safety information.

Responsibilities

• Contributes to the development & maintenance of product safety profile.
• Involved in safety surveillance activities, including monitoring adverse events and other safety information to manage the safety profile of company products.
• Collaborates with medical monitors and other functional groups in identification, analysis, and reporting of safety-related trends or concerns.
• Evaluates safety data from pre-clinical studies, clinical studies, literature and other sources to establish safety profile and manage risk to patients.
• Provides medical input into the identification and utilization of data sources and database searches for signal evaluation.
• Discusses results of data evaluation with pharmacovigilance safety review team, drug safety committee and/or key stakeholders.
• Provides inputs to literature search strategy and review to identify relevant literature for safety analysis.
• Reviews Risk Management Plans (RMP)/Risk Evaluation and Mitigation Strategy (REMS), provides expertise on safety content, and drives risk minimisation activities in line with global regulatory requirements.
• Ensures risk minimisation strategies are implemented in relevant documents (e.g., product reference safety information).
• Collaborates with external provider representatives in the preparation and review of aggregate reports with oversight over safety concerns, benefit-risk evaluation, and conclusions.
• Provides medical oversight of external vendors on the medical review of ICSRs.
• Delivers medical inputs to safety evaluation documents in response to internal or regulatory authority requests.
• Provides medical inputs in responding to safety questions from regulatory authorities and partners in collaboration with service providers and cross-functional teams.
• Reviews and provides medical inputs to safety sections of CCDS, local label updates, health hazard analyses, QA trend analysis, device hazard lists, CERs, etc.
• Understands the role of QPPV and contributes to maintaining the pharmacovigilance system and process.
• Provides inputs to pharmacovigilance documents like PSMF, SDEA.
• Provides input and review for key regulatory or clinical documents (e.g., SMPs, protocols, IBs, SAE/SUSARs, safety sections of DSUR, ASR, CSR) related to pharmacovigilance.
• Leads initiatives for process improvement and consistency in aggregate reporting, signal management, risk management plan preparation, and responding to ad-hoc safety questions.
• Supports pharmacovigilance audit/inspection preparation and CAPA management.
• Participates in internal pharmacovigilance committee meetings and joint safety meetings with partners.
• Contributes to the preparation/revision of SOPs and guidance to ensure pharmacovigilance compliance.
• Meets pharmacovigilance commitments to regulatory authorities with respect to marketing authorization.
• Maintains good pharmacovigilance practices (ICH, Eudravigilance, local regulations, etc.).
• Trains and mentors team members.
• Other Drug Safety Physician responsibilities include maintaining readiness for internal audits or regulatory inspections and knowledge of case processing, expedited reporting, and safety database concepts.
• Proactively raises concerns/issues to senior management in a timely and appropriate manner to ensure quality and integrity of issues/events.
• Demonstrates leadership and collaborates effectively across teams and with external stakeholders; ensures oversight of CRO activities.
• Strong organizational skills with the ability to prioritize independently with minimal supervision.

Qualifications

• MBBS/PhD/MD with 7+ years of pharmacovigilance experience in the pharmaceutical industry, clinical care, or academia.
• Knowledge of biopharmaceutical industry, drugs, indications, and applicable guidelines/regulations for pharmacovigilance.
• High degree of professionalism, maturity, business understanding and passion.
• Strong written and verbal communication skills and interpersonal skills with meticulous attention to detail.
• Ability to collaborate effectively with internal and external stakeholders and influence decision-making.
• Knowledge of common data processing software such as MS Office (Excel, PowerPoint, Word).

Job Location:
Seniority level: Director

Employment type: Full-time

Job function: Health Care Provider

Industries: Pharmaceutical Manufacturing

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