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 workplace 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 team-oriented 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 guidel

📌 Mana Gurugram (India)
🏢 Sun Pharmaceutical Industries
📍 India