Job Title: Associate Manager – PSS
📍 Location: Pune
🏢 Category: Clinical
🆔 Job ID: 254798
Job Overview
The Associate Manager – PSS is responsible for managing, coordinating, and overseeing all PSS (Project Support Services) operations related to adverse events and expedited safety reports, ensuring compliance with client, regulatory, and global standards.
This role includes line management of junior PSS staff, conducting performance reviews, handling HR-related issues, and assisting Senior PSS Management in resource allocation. The position demands leadership, compliance awareness, and process optimization within a regulated pharmacovigilance environment.
The post holder must comply with all applicable Health and Safety regulations (Health and Safety at Work Act 1974, COSHH 1989, EC Directives 1992/3) as outlined in the company’s Health and Safety Manual.
Key Responsibilities
1. Global PVA / SLA / ICA Management
Maintain and update PVAs, SLAs, and ICAs through their review cycles.
Archive and manage Global PVAs in SharePoint.
Handle Global PVA-related queries.
Maintain and update Vigilance Agreements in line with upcoming needs.
2. Local PVA Management
Support maintenance and updates of local PVAs through their review cycles.
Manage local PVA archiving and SharePoint maintenance.
Handle local PVA-related queries.
3. PV Alliance & Compliance Support
Assist in Local Operating Company (LOC) bi-annual reports (two cycles/year).
Support PSMF (Pharmacovigilance System Master File) updates (twice/year).
Manage Safety Agreements mailbox (email categorization, task assignment).
Core Competencies & Skills
Customer Focus: Dedicated to delivering superior service.
Innovation: Embrace and drive change.
Scientific Excellence: Pursue continuous improvement.
Team Collaboration: Work effectively across teams.
Result Orientation: Achieve targets efficiently.
Key Abilities
Strong relationship-building and interpersonal skills.
Expertise in performance assessment and staff development.
Effective coaching, mentoring, and leadership abilities.
Capable of independent decision-making and risk management.
Skilled in process analysis, problem-solving, and resource optimization.
Multitasking in a complex, fast-paced environment.
Excellent communication (verbal, written, presentation) skills.
Attention to detail and regulatory compliance mindset.
Financially intuitive with awareness of cost-effectiveness.
Knowledge Requirements
Medical and Drug Terminology
Good Clinical Practice (GCP) related to safety documentation
Worldwide regulatory requirements for AE/SAE reporting
Familiarity with Medical Device Reporting (preferred)
Understanding of aggregate reporting (preferred)
ICH Guidelines and Risk Management awareness
MS Office proficiency (Word, Excel, Outlook, SharePoint)
Leadership & Collaboration
Inspire, motivate, and engage PSS staff.
Collaborate effectively with PSS Management Team and cross-functional teams.
Promote knowledge sharing and continuous improvement.
Anticipate and resolve potential operational challenges.
Educational Qualifications
Preferred Degrees:
Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related fields.
Minimum Qualifications (any one):
|
Education Level |
Required Experience |
Leadership Experience |
|---|---|---|
|
Non-degree |
6–7 years safety exp. |
2 years |
|
Associate Degree |
5–6 years safety exp. |
2 years |
|
Associate Degree RN |
5–6 years safety exp. |
2 years |
|
BS/BA |
4–5 years relevant exp. |
1–2 years |
|
MS/MA |
3–4 years relevant exp. |
1–2 years |
|
PhD / PharmD |
2–3 years relevant exp. |
0–2 years |
🧠 For PharmD, one year of residency or fellowship can be considered relevant experience.
Experience Definitions
Safety Experience: AE/SAE processing, narrative writing, safety database use, regulatory submissions.
Relevant Experience: Medical Affairs, Clinical Data Management, Data Entry, Monitoring, Regulatory Affairs, Quality Assurance.
Leadership Experience: Oversight of team deliverables, work allocation, coordination in a matrix environment.
Preferred Certifications
EudraVigilance Certification (Highly Desirable)
Work Environment & Travel
Office / Remote Hybrid
Travel: Up to 10% (including overnight stays as needed)
No special working conditions currently applicable.
Equal Opportunity Statement
We are committed to providing equal employment opportunities and supporting reasonable accommodations as required.
📎 Learn more about our EEO & Accommodation Policy [here].
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