SERM Physician / Scientist - Sr Associate - GO/JC/4576/2026

Golden Opportunities; Mumbai; Hybrid; INR 1,500,000 - 2,300,000; Full time

Job summary

Golden Opportunities is seeking a SERM Physician/Scientist to lead signal detection, evaluation, and risk assessment for assigned products across PAN INDIA (Mumbai, Pune, Bangalore, Noida) with a hybrid work model. You will deliver safety evaluations, support regulatory interactions, and contribute to safety governance activities.

The role requires 3–7 years of PV experience, MBBS/MD or Life Science degree, and distance education not accepted.

Qualifications

• Total and relevant experience: 3–7 years.
• MBBS/MD or Life Science degree required.
• Distance education not accepted, MCI certification added advantage.

Responsibilities

• Perform signal detection, evaluation, and risk assessment for assigned products.
• Deliver fit‑for‑purpose safety evaluations with clear conclusions for internal and regulatory stakeholders.
• Contribute to protocols, program documents, and safety governance activities.
• Identify, assess, and elevate safety signals/issues with recommended risk mitigation strategies.
• Support health authority responses, audits, and inspection readiness activities.
• Drive process improvements and ensure compliance with ICH, GVP, and global PV regulations.
• Collaborate within cross‑functional matrix teams and manage multiple deliverables with quality and timelines.
• Provide Medical inputs on pharmacovigilance and risk management planning; contribute to RMPs.
• Drive signal detection, evaluation, and labeling recommendations using safety databases and literature.
• Author and review aggregate safety reports (PSUR/PBRER, Annual Reports) and regulatory submissions.
• Provide medical oversight for protocols, investigator brochures, informed consents, study reports, and safety governance forums.
• Evaluate and elevate safety signals/issues; recommend risk mitigation strategies and labeling updates.
• Collaborate with cross‑functional teams (Clinical, Regulatory, Product Scientists) for safety decision‑making.
• Ensure inspection readiness, audit compliance, and adherence to global PV regulations (ICH, GVP).

Skills

signal detection

evaluation

risk assessment

Education

MBBS/MD

Life Science Graduate

Job description

Job Details

Job Title: SERM Physician / Scientist

Job Location: PAN INDIA - Mumbai, Pune, Bangalore, Noida

Work Model: Work from Office / Hybrid

Candidate Expectations

Total and Relevant Experience – 3 Years to 7 Years

Candidate Location - Anywhere

Skills – signal detection, evaluation, and risk assessment

Candidate Industry (Pharma)

Diversity – No

Education and Certification

Qualification: (MBBS/MD) / Life Science Graduate

Specific Remarks: Distance education not accepted.

Certification: MCI added advantage

Detailed Job Description

• Perform signal detection, evaluation, and risk assessment for assigned products
• Deliver fit‑for‑purpose safety evaluations with clear conclusions for internal and regulatory stakeholders
• Contribute to protocols, program documents, and safety governance activities
• Identify, assess, and elevate safety signals/issues with recommended risk mitigation strategies
• Support health authority responses, audits, and inspection readiness activities
• Drive process improvements and ensure compliance with ICH, GVP, and global PV regulations
• Collaborate within cross‑functional matrix teams and manage multiple deliverables with quality and timelines
• Provide Medical inputs on pharmacovigilance and risk management planning; contribute to benefit–risk assessments and Risk Management Plans (RMPs)
• Drive signal detection, evaluation, and labeling recommendations using safety databases and literature
• Author and review aggregate safety reports (PSUR/PBRER, Annual Reports) and regulatory submissions
• Provide medical oversight for protocols, investigator brochures, informed consents, study reports, and safety governance forums
• Evaluate and elevate safety signals/issues; recommend risk mitigation strategies and labeling updates
• Collaborate with cross‑functional teams (Clinical, Regulatory, Product Scientists) for safety decision‑making
• Ensure inspection readiness, audit compliance, and adherence to global PV regulations (ICH, GVP)

Key Skills

signal detection, evaluation, and risk assessment

Other Specific Remarks

Additional Requirements: Proper documents for entire career and PF Form 16 Mandatory