Manager-2

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