Fortrea is hiring for the role of Associate Manager PSS in Pune, India. This position is a fantastic opportunity for professionals with strong expertise in pharmacovigilance, patient safety solutions (PSS), and regulatory safety reporting. If you are looking to advance your career in drug safety management with leadership responsibilities, this role is tailor-made for you.
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✅ Key Responsibilities
As an Associate Manager PSS, your responsibilities will include:
- Line-managing PSS staff, conducting performance reviews, and ensuring HR compliance.
- Overseeing adverse event (AE/SAE) reporting, expedited safety reports (ESRs), and global regulatory submissions.
- Ensuring accuracy in MedDRA coding, narrative writing, and clinical safety data entry.
- Coordinating pharmacovigilance processes for both marketed and investigational products.
- Managing EudraVigilance activities, aggregate reporting, and risk management compliance.
- Supporting clinical data management teams in SAE reconciliation.
- Training and mentoring junior staff, ensuring compliance with ICH-GCP and global PV regulations.
- Leading client communications, audits, and presentations on PSS capabilities.
🎓 Qualifications & Experience
Minimum Requirements:
- Degree in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related field.
- Strong knowledge of pharmacovigilance, GCP, ICH guidelines, and global regulatory requirements.
- 4–7 years of safety experience depending on qualification level.
- At least 1–2 years in team leadership roles.
- Strong communication, leadership, and client management skills.
Preferred:
- EudraVigilance certification.
- Knowledge of Medical Device Reporting and aggregate safety reporting.
- Experience working in pharma, biotech, or CROs.
🌟 Benefits
- Hybrid working model (Office + Remote flexibility).
- Opportunity to lead pharmacovigilance operations across global projects.
- Career advancement in drug safety and patient safety solutions.
- Exposure to international clients, regulatory authorities, and industry leaders.
📅 Application Deadline
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