Location: India (Remote Work Possible)
Job Type: Permanent
Are you looking for exciting career opportunities in Regulatory Affairs, Pharmacovigilance, or Medical Writing? ProductLife Group (PLG), a global leader in life sciences consulting, is hiring for five key roles in India. If you have experience in GMP compliance, drug safety, medical review, or toxicology assessments, this could be your next career move!
1. Associate Consultant – Regulatory Affairs (VAF 154)
Department: Regulatory Affairs & Operations
Job Description:
- Prepare and submit GMP Clearance applications to TGA/Medsafe.
- Support regulatory, quality, and compliance activities for pharmaceuticals, biologics, and medical devices.
- Assist in responding to regulatory agency queries.
- Review and update quality documentation.
Qualifications:
- Bachelor’s in Pharmaceutical Sciences or related field.
- 3+ years in Australian/New Zealand Regulatory Affairs or Quality.
- Knowledge of TGA/Medsafe regulations.
- Strong communication and project management skills.
2. Medical Reviewer – Pharmacovigilance (VAF 192, 193, 194)
Department: Safety & Vigilance
Job Description:
- Perform medical review of ICSRs (spontaneous, literature, clinical studies).
- Assess seriousness, causality, and benefit-risk evaluations.
- Support audits and mentor junior team members.
Qualifications:
- MBBS/MD degree.
- 2-4 years in Pharmacovigilance (pharma or service provider).
- Experience with safety databases (Argus, Veeva, etc.).
- Strong analytical and communication skills.
3. Pharmacovigilance Coordinator (Data Officer) – VAF 199
Department: Safety & Vigilance
Job Description:
- Data entry & QC of adverse event reports.
- Manage follow-up requests and client email communications.
- Ensure compliance with GVP, GCP, and FDA regulations.
Qualifications:
- Pharmacy/Science graduate.
- 1-2 years in PV case processing (preferred).
- Knowledge of safety databases (Argus, SafetyEasy).
- Organized, detail-oriented, and proficient in English.
Working Hours: 1:30 PM – 9:30 PM IST (CET coverage).
4. Case Specialist – Pharmacovigilance (VAF 191)
Department: Safety & Vigilance
Job Description:
- Medical evaluation & QC of ICSRs.
- Data entry in safety databases (Argus, SafetyEasy).
- Conduct follow-ups & causal relationship assessments.
Qualifications:
- Doctor/Pharmacist with 3-4 years in PV.
- Experience with line management (preferred).
- Strong knowledge of GVP, GCP, and FDA regulations.
5. Medical Writing Specialist – Toxicology (VAF 175)
Department: Regulatory Affairs & Operations
Job Description:
- Conduct toxicology risk assessments (excipients, impurities, leachables).
- Prepare PDE/OEL monographs & non-clinical CTD modules.
- Perform QSAR genotoxicity assessments (ICH M7).
Qualifications:
- Qualified Toxicologist (2+ years’ experience).
- Expertise in DEREK, SARAH, TOXTREE, OECD Toolbox.
- Experience in regulatory submissions (Modules 2.4-2.7, 4, 5).
About ProductLife Group (PLG)
ProductLife Group is a global consulting firm specializing in Regulatory Affairs, Pharmacovigilance, and Medical Devices. With a strong presence in Europe, Asia, and the Americas, PLG supports pharmaceutical and biotech companies in compliance, drug safety, and regulatory submissions.
Why Join PLG?
✅ Remote work flexibility
✅ Global exposure in life sciences
✅ Career growth & learning opportunities
✅ Competitive salary & benefits
Application Link For Associate Consultant – Regulatory Affairs
Application Link For Medical Reviewer – Pharmacovigilance
Application Link For Pharmacovigilance Coordinator (Data Officer)
Application Link For Case Specialist – Pharmacovigilance
Application Link For Medical Writing Specialist – Toxicology
