SERM Physician / Scientist - Sr. Associate

Golden Opportunities; Dadri, Pune District, Bengaluru; Hybrid; INR 900,000 - 1,300,000; Full time

Job summary

Golden Opportunities seeks a Pharmacovigilance professional with 3–7 years of experience to manage signal detection, risk assessment, and safety evaluations for multiple products across PAN INDIA. The role requires MBBS/MD or life sciences background, with distance education not accepted and MCI certification as an advantage.

Responsibilities include drafting safety reports, supporting health authority interactions, audits, and ensuring compliance with ICH and GVP.

Qualifications

• Total and Relevant Experience 3–7 years.
• Education: MBBS/MD or Life Science Graduate.
• Distance education not accepted.
• Certification: MCI 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.
• 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).

Skills

Signal detection

Safety evaluation

Risk assessment

Pharmacovigilance

Education

MBBS/MD / Life Science Graduate

Job description

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

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 .