JOB DESCRIPTION: PHARMACOVIGILANCE SERVICES SENIOR MANAGER
Senior Leadership / Management Role
Company: Accenture
Job Title: Pharmacovigilance Services Senior Manager
Job ID: AIOC-S01623460
Location: Bengaluru, Karnataka, India
Employment Type: Full Time
Job Category: Pharmacovigilance Operations
Primary Skill: Pharmacovigilance & Drug Safety Surveillance
Designation: Senior Manager
Experience: 12–14 years (job heading); 15+ years (detailed job description)
Qualifications: MSc / B.Pharm / M.Pharm
Language: English – Proficient
1. ABOUT THE ROLE
The Pharmacovigilance Services Senior Manager position at Accenture is a senior leadership role responsible for managing end-to-end pharmacovigilance service delivery for global pharmaceutical clients.
The individual will oversee pharmacovigilance operations, manage resources, lead multiple teams, ensure regulatory compliance, maintain client relationships and drive continuous improvement initiatives.
The role combines three major responsibilities:
Operational Leadership: Managing pharmacovigilance delivery, quality and productivity.
People Leadership: Managing Team Leads, Tower Leads and operational teams.
Client Management: Managing client expectations, escalations, risks and service delivery commitments.
The primary objective is to ensure efficient, high-quality and compliant pharmacovigilance operations while protecting patient safety.
2. EDUCATIONAL QUALIFICATIONS
Required qualifications:
Bachelor of Pharmacy (B.Pharm).
Master of Pharmacy (M.Pharm).
MSc – relevant Life Sciences discipline.
Preferred advanced qualifications:
PharmD.
PhD.
Other relevant postgraduate qualifications.
3. EXPERIENCE REQUIREMENTS
The job posting mentions two different experience requirements:
Job heading: 12–14 years.
Detailed job description: 15+ years.
The detailed requirements specify a minimum of 12 years of experience in pharmacovigilance, drug safety or a related field.
Relevant experience should include:
Pharmacovigilance Operations Management.
Individual Case Safety Reporting.
Aggregate Safety Reporting.
Signal Detection and Management.
Global Drug Safety Operations.
Regulatory Compliance.
Quality Management.
Client and Stakeholder Management.
Team and Resource Management.
Project and Service Delivery.
4. KEY ROLES AND RESPONSIBILITIES
A. PHARMACOVIGILANCE OPERATIONS MANAGEMENT
Oversee end-to-end pharmacovigilance operations.
Ensure efficient delivery of safety services to pharmaceutical clients.
Manage individual case safety reporting activities.
Maintain oversight of aggregate safety reporting.
Ensure appropriate safety signal monitoring.
Monitor operational performance and productivity.
Ensure compliance with regulatory timelines.
Maintain high standards of data quality and integrity.
Identify operational gaps and implement corrective actions.
Ensure uninterrupted service delivery.
B. ICSR MANAGEMENT AND OVERSIGHT
The Senior Manager will provide strategic and operational oversight of Individual Case Safety Report processing.
Key responsibilities include:
Oversee end-to-end ICSR processing.
Ensure timely adverse event reporting.
Monitor case intake and case identification.
Oversee case processing and medical coding quality.
Ensure accurate safety documentation.
Monitor serious and non-serious case reporting.
Ensure regulatory submission timelines are achieved.
Monitor case backlogs and ageing.
Review case processing performance.
Ensure compliance with global reporting requirements.
C. AGGREGATE SAFETY REPORT MANAGEMENT
Provide project management oversight for aggregate safety reports.
Important reports include:
Periodic Safety Update Reports (PSURs).
Periodic Benefit-Risk Evaluation Reports (PBRERs).
Development Safety Update Reports (DSURs).
Aggregate safety summaries.
Other periodic regulatory safety reports.
Responsibilities:
Monitor aggregate reporting deliverables.
Ensure adherence to reporting schedules.
Coordinate with medical writers and safety physicians.
Ensure availability of accurate safety data.
Monitor report quality and completeness.
Ensure regulatory compliance.
Manage project timelines and deliverables.
Coordinate with internal and external stakeholders.
D. SIGNAL DETECTION AND MANAGEMENT
Oversee safety data monitoring activities.
Identify potential safety signals.
Ensure appropriate signal detection methodologies.
Review safety signal evaluation outcomes.
Coordinate signal investigation activities.
Support benefit-risk assessments.
Monitor signal management deliverables.
Ensure appropriate escalation of emerging safety concerns.
Collaborate with safety physicians and medical reviewers.
Support appropriate safety-related decisions.
E. REGULATORY COMPLIANCE MANAGEMENT
Ensure pharmacovigilance operations comply with applicable global regulatory requirements.
Important regulatory frameworks include:
ICH Guidelines.
US FDA pharmacovigilance requirements.
EMA pharmacovigilance requirements.
EU Good Pharmacovigilance Practices (GVP).
Applicable global Health Authority requirements.
Client-specific SOPs and work instructions.
Responsibilities:
Monitor regulatory compliance.
Ensure timely regulatory submissions.
Maintain inspection readiness.
Review compliance performance.
Identify regulatory gaps.
Coordinate regulatory issue resolution.
Ensure adherence to internal policies.
Maintain appropriate documentation.
F. QUALITY MANAGEMENT AND CAPA
Establish and maintain quality management systems.
Monitor pharmacovigilance quality performance.
Ensure data accuracy, completeness and consistency.
Review quality metrics.
Identify recurring operational errors.
Investigate quality-related issues.
Coordinate Corrective and Preventive Actions (CAPA).
Monitor CAPA effectiveness.
Support internal and external audits.
Ensure inspection readiness.
Drive continuous quality improvement.
G. CLIENT MANAGEMENT AND STAKEHOLDER ENGAGEMENT
Maintain strong relationships with pharmaceutical clients.
Interact with client management at different organisational levels.
Coordinate with client ESP Management representatives.
Manage client expectations.
Address client concerns.
Resolve service delivery escalations.
Communicate operational risks.
Provide regular performance updates.
Participate in governance meetings.
Ensure alignment between client requirements and operational delivery.
H. RESOURCE AND WORKFORCE MANAGEMENT
One of the most important responsibilities of this position is managing people and resources.
Responsibilities include:
Determine staffing requirements.
Ensure optimum resource utilisation.
Coordinate recruitment and hiring activities.
Work with HR and recruitment teams.
Support timely mobilisation of employees.
Define job descriptions when required.
Participate in candidate selection.
Monitor employee productivity.
Manage resource allocation.
Ensure adequate operational coverage.
Address workforce-related issues.
I. TEAM LEADERSHIP AND PEOPLE MANAGEMENT
Manage Team Leads and Tower Leads.
Provide guidance and mentorship.
Establish team performance expectations.
Monitor individual and team performance.
Evaluate productivity against KPIs.
Monitor compliance with SLAs.
Address performance-related issues.
Support employee development.
Promote accountability and collaboration.
Monitor employee morale.
Support career development and succession planning.
J. SERVICE DELIVERY AND PERFORMANCE MANAGEMENT
Ensure efficient delivery of pharmacovigilance services.
Monitor operational KPIs.
Ensure compliance with contractual SLAs.
Track project performance.
Review productivity and quality metrics.
Identify performance gaps.
Implement corrective actions.
Manage delivery-related risks.
Ensure business continuity.
Maintain high service delivery standards.
K. MIS AND OPERATIONAL REPORTING
The role requires strong knowledge of Management Information Systems (MIS) and operational analytics.
Responsibilities include:
Analyse operational MIS reports.
Monitor daily, weekly and monthly performance.
Review case processing metrics.
Monitor productivity.
Analyse quality trends.
Track case backlogs.
Monitor SLA performance.
Identify operational deviations.
Recommend corrective actions.
Present performance updates to senior management and clients.
L. RISK AND ESCALATION MANAGEMENT
Identify operational risks.
Manage client escalations.
Resolve service delivery issues.
Coordinate cross-functional issue resolution.
Work with process owners.
Organise cross-project teams when required.
Review recommendations.
Monitor corrective actions.
Ensure timely closure of escalations.
M. PROCESS OPTIMISATION AND CONTINUOUS IMPROVEMENT
Identify opportunities for process improvement.
Drive automation initiatives.
Promote standardisation.
Improve operational efficiency.
Reduce processing errors.
Improve productivity.
Implement industry best practices.
Support technology adoption.
Drive innovation within pharmacovigilance operations.
Improve scalability of service delivery.
5. IMPORTANT PHARMACOVIGILANCE KNOWLEDGE
A Senior Manager should have a strong understanding of the following areas.
|
Area |
Important knowledge |
|---|---|
|
ICSR Management |
Case intake, processing, review and submission |
|
Aggregate Reporting |
PSUR, PBRER and DSUR |
|
Signal Management |
Signal detection, validation and evaluation |
|
Risk Management |
Risk assessment and benefit-risk evaluation |
|
Regulatory Affairs |
ICH, FDA, EMA and GVP |
|
Quality Management |
Quality metrics, audits and CAPA |
|
Clinical Safety |
SAE and SUSAR reporting |
|
Post-Marketing Safety |
Spontaneous and solicited reports |
|
Database Management |
Argus and ARISg |
|
Operations Management |
KPIs, SLAs, MIS and productivity |
6. IMPORTANT REGULATORY GUIDELINES
The following guidelines are particularly important for this position.
|
Guideline |
Description |
|---|---|
|
ICH E2A |
Clinical Safety Data Management |
|
ICH E2B |
Electronic Transmission of Individual Case Safety Reports |
|
ICH E2C |
Periodic Benefit-Risk Evaluation Reports |
|
ICH E2D |
Post-Approval Safety Data Management |
|
ICH E2E |
Pharmacovigilance Planning |
|
ICH E2F |
Development Safety Update Reports |
|
EU GVP |
Good Pharmacovigilance Practices |
|
FDA Regulations |
US drug safety reporting requirements |
7. SAFETY DATABASES AND TECHNOLOGY
Experience with pharmacovigilance systems is desirable.
Important systems mentioned in the job description:
Oracle Argus Safety.
ArisGlobal (ARISg).
Additional useful technology knowledge:
Safety signal detection tools.
Safety data analytics.
Pharmacovigilance reporting platforms.
Quality management systems.
Case processing automation.
Operational dashboards.
MIS reporting tools.
Advanced Microsoft Excel and PowerPoint.
8. KEY PERFORMANCE INDICATORS (KPIs)
A Senior Manager should understand how to monitor and improve operational performance.
|
KPI |
What it measures |
|---|---|
|
Case Processing Timeliness |
Cases completed within required timelines |
|
Regulatory Submission Compliance |
On-time regulatory submissions |
|
Case Quality |
Accuracy and completeness of safety cases |
|
Error Rate |
Frequency of processing errors |
|
Productivity |
Cases processed per employee |
|
Backlog |
Number of pending cases |
|
SLA Compliance |
Achievement of contractual commitments |
|
CAPA Closure |
Timely closure of corrective actions |
|
Training Compliance |
Completion of mandatory training |
|
Resource Utilisation |
Effective deployment of employees |
|
Client Satisfaction |
Client feedback and service quality |
9. IMPORTANT MANAGEMENT RESPONSIBILITIES
This position extends beyond technical pharmacovigilance knowledge.
The Senior Manager will also be responsible for:
Business Management
Directing a business group or sub-division.
Managing budgets.
Managing resources.
Monitoring project delivery.
Supporting business strategy.
Financial Management
Monitoring operational expenditure.
Supporting budget planning.
Ensuring effective resource utilisation.
Monitoring financial and operational performance.
Human Resource Management
Hiring and staffing.
Employee performance management.
Promotion and compensation recommendations.
Employee relations.
Disciplinary actions.
Employee retention and development.
Client Relationship Management
Managing client interactions.
Handling escalations.
Reviewing service delivery.
Managing governance meetings.
Maintaining client satisfaction.
10. REQUIRED LEADERSHIP AND SOFT SKILLS
Strategic thinking.
Leadership and team management.
Decision-making.
Client relationship management.
Stakeholder management.
Conflict resolution.
Communication and presentation.
Financial and resource management.
Analytical thinking.
Problem-solving.
Change management.
Negotiation.
Time management.
Business process management.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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New Hampshire |Oklahoma :
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Tuscaloosa |D.C :
Washington |Delaware :
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Bavaria |Bavaria :
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Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Germany | GErmany |Lower Saxony :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Norway | NOrway |Romania :
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Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
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Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Kyiv |Lima Region :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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