Manager-2

SUN PHARMA; Gurugram District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharma in Gurugram is seeking a Manager-Medical Reviewer - ICSR to lead medical review of ADR cases, perform causality assessments, and ensure high quality in all PV activities within Argus Safety.

You will coordinate sponsor reviews, support regulatory filings, develop risk management plans, and train team members while maintaining compliance with global guidelines; MBBS/MD with 2+ years of experience is required.

Qualifications

• MBBS or MD required.
• Experience: 2+ years in medical review or pharmacovigilance.

Responsibilities

• ADR processing and medical review of ADR cases in Argus Safety.
• Perform listedness assessment of ADR cases in Argus Safety.
• Medical review of cases reported from company-sponsored clinical trials in Argus Safety.
• Causality assessment notes for BE CTs.
• Coordinate sponsor reviews for cases and ensure quality standards.

Education

MBBS/MD

Job description

Job Title

Manager-Medical Reviewer - ICSR

Business Unit

Global Pharmacovigilance

Job Grade

G11A

Location

Gurugram

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

List Of Responsibilities/Job Function

• Adverse Drug Reaction (ADR) processing:
• Perform medical review of ADR cases in Argus Safety
• Perform listedness assessment of ADR cases in Argus Safety
• Perform medical review of cases reported from the company sponsored clinical trials in Argus Safety
• Causality assessment note for BE CTs
• Perform activity of identification of clustering events in China monthly
• Perform sponsor reviews for the cases
• Quality standards and trainings:
• Ensure compliance to SOPs and regulatory guidelines and zero critical errors in medical review of cases as per quality metrics (QM).
• To attend and conduct assigned training sessions for the team
• Risk Management Plans: Preparation of Risk Management Plans (RMPs)
• HHE: Draft/review Health Hazard Evaluation (HHE) reports
• Targeted Follow up Activity: Perform routine Targeted Follow up Activity
• Process enhancement and compliance:
• Ensuring compliance to applicable regulations and guidelines
• Others: Receive applicable training for self -development

Competencies Required

Technical Competencies:

• Domain knowledge: Medical & therapeutic area knowledge; thorough knowledge of drug development process and pharmacology; Knowledge of Pharmacovigilance and Case processing
• Knowledge of regulatory and scientific guidelines
• Literature review & interpretation skills: Performing critical content reviews with clear objectives; logical and accurate research data interpretation
• Sound working knowledge and skills relating to Microsoft Office Applications and Argus safety database
• Keeping abreast of new relevant information in pharmaceutical industry, and undergo regular self-training to enhance skills

Behavioral Competencies / Soft Skills

• Interpersonal skills and team spirit with willingness to help others in achieving targets
• Problem solving skills & willingness to work in tight schedules if required by the organization to support drug filings and approvals
• Communication skills

Job Requirements

Educational Qualification –

MBBS / MD

Experience –

Tenure : 2+Years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

Disclaimer:

The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).