01 Aug
|
Latinum Hr Solutions
|
India
01 Aug
Latinum Hr Solutions
India
Job Description
We're Hiring | SERM Physician (Safety Evaluation & Risk Management)
n
n
Are you passionate about Drug Safety, Pharmacovigilance, and Medical Risk Assessment? We are looking for an experienced SERM Physician to join our global Pharmacovigilance team and play a critical role in ensuring patient safety throughout the product lifecycle.
n
n
Eligibility Criteria
n
•Position: SERM Physician
n
• Location: PAN India
n
• Experience: 5+ Years
n
• Salary: Up to 35 LPA (Depending on Exp)
n
• Employment Type: Full-time
n
• Degree : MBBS / MD
n
n
Key Responsibilities
n
• Provide medical expertise in Pharmacovigilance activities, including benefit-risk evaluation and safety strategy.
n
• Lead signal detection, signal validation, and signal evaluation using safety databases, clinical data, and scientific literature to identify emerging safety concerns.
n
• Author, review, and provide medical oversight for aggregate safety reports, including:
n
• PSUR/PBRER
n
• Annual Safety Reports
n
• Regulatory safety submissions
n
• Develop, review, and contribute to Risk Management Plans (RMPs), ensuring appropriate risk minimization strategies throughout the product lifecycle.
n
• Evaluate safety signals and adverse event trends, recommending appropriate risk mitigation measures, labeling updates, and regulatory actions when required.
n
• Provide medical review and oversight for:
n
• Clinical Study Protocols
n
• Investigator Brochures (IB)
n
• Informed Consent Forms (ICF)
n
• Clinical Study Reports (CSR)
n
• Safety governance documentation
n
• Collaborate closely with cross-functional global teams, including Clinical Development, Regulatory Affairs, Medical Affairs, Product Scientists, and Pharmacovigilance stakeholders to support informed safety decisions.
n
• Ensure inspection readiness by maintaining compliance with global Pharmacovigilance regulations, including ICH Guidelines and GVP Modules.
n
n
• Mandatory hands-on experience in:
n
• Aggregate Safety Report Authoring & Review (PSUR/PBRER, Annual Reports)
n
• Signal Detection & Signal Evaluation
n
• Strong understanding of:
n
• Benefit-Risk Assessment
n
• Risk Management Plans (RMP)
n
• Global Pharmacovigilance regulations
n
• ICH Guidelines
n
• GVP Modules
n
• Regulatory safety reporting requirements
n
• Excellent analytical, medical writing, stakeholder management, and communication skills.
n
• Experience working within global cross-functional matrix organizations will be highly preferred.
n
n
Interested candidates can share at &
n
n
If this chance matches your expertise—or you know someone who would be a great fit—please feel free to connect or share this post within your network.
📌 SERM Physician (India)
🏢 Latinum Hr Solutions
📍 India