Job Title: Associate Manager – PSS
📍 Location: Pune
📂 Category: Clinical
🆔 Job ID: 254798
Job Overview
The Associate Manager – PSS will:
Line manage junior PSS staff including performance reviews and HR-related issues.
Support Senior PSS Management in resource allocation to projects.
Oversee PSS operations related to adverse events (AEs) and expedited safety reports, ensuring high-quality, timely submissions to clients and regulatory agencies.
Ensure compliance with global and local safety agreements while maintaining client satisfaction.
Adhere to Health and Safety regulations including the Health and Safety at Work Act 1974, COSHH 1989, and EC Directives 1992/3.
Key Responsibilities
Global PVA/SLA/ICA Management
Maintain PVAs/SLAs/ICAs through their review cycle.
Archive, file, and manage global PVAs in SharePoint.
Address global PVA/SLA/ICA queries.
Maintain Vigilance Agreements and update as needed.
Local PVA Management
Support maintenance and updates of local PVAs.
Archive and file local PVAs in SharePoint.
Handle local PVA-related queries.
PV Alliance & Compliance Support
Support LOC bi-annual reports (2 cycles/year).
Assist in PSMF maintenance (2 updates/year).
Manage Safety Agreements mailbox (categorization, task assignment).
Qualifications – Minimum Required
Strong focus on customer service, innovation, scientific progress, teamwork, and results.
Relationship-building and interpersonal skills.
Proven ability in performance assessment, coaching, and team development.
Strong problem-solving and process improvement capabilities.
Ability to manage staff independently and coordinate day-to-day operations.
Excellent communication (verbal, written, presentation) and leadership skills.
High accuracy, attention to detail, and regulatory compliance awareness.
Knowledge of:
Medical and drug terminology
GCP (Good Clinical Practice)
Regulatory requirements for AE/SAE reporting (marketed & investigational products)
ICH guidelines
Risk Management & Pharmacovigilance regulations
MS Office & Windows proficiency.
Financial acumen.
Preferred Qualifications
Education & Experience (any one of the following):
Non-degree + 6–7 years safety experience* (incl. 2 years leadership)
Associate degree + 5–6 years safety experience* (incl. 2 years leadership)
Associate degree RN + 5–6 years safety experience* (incl. 2 years leadership)
BS/BA + 4–5 years relevant experience** (incl. 1–2 years leadership)
MS/MA + 3–4 years relevant experience** (2–3 years safety exp., incl. 1–2 years leadership)
PhD/PharmD + 2–3 years relevant experience** (1–2 years safety exp., incl. 0–2 years leadership). PharmD fellowship/residency counts as experience.
Preferred Degrees: Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related fields.
Certifications: EudraVigilance certification desirable.
Experience Definitions
Safety Experience: AE/SAE processing, narratives, queries, safety databases, regulatory submissions.
Relevant Experience: Pharma/biotech/CRO in areas such as Medical Affairs, CDM, Monitoring, Regulatory Affairs, Quality Assurance.
Team Leadership Experience: Managing team deliverables in a matrix environment, assigning work, coordinating staff, and achieving team goals.
Work Environment / Travel
Travel up to 10% (overnight stays possible).
Office or remote setting.
No special conditions.
✅ Equal Opportunity: This employer ensures non-discrimination and provides accommodations as per applicable laws.
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