Pharmacovigilance Services Sr Manager

8103 Acc Sol Pvt Ltd Company; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Accenture in Bengaluru seeks a Pharmacovigilance Services Sr Manager to lead end-to-end pharmacovigilance operations and resource mobilization, ensuring compliant service delivery.

You will partner with ESP management to oversee safety data handling, case processing, signal detection, and regulatory reporting while mentoring teams and driving process improvements.

Qualifications

• Bachelor's or Master's in Pharmacy or Life Sciences; advanced degree preferred.
• Minimum 12+ years in pharmacovigilance/drug safety with emphasis on case reporting and safety signal monitoring.
• Strong knowledge of ICH, FDA, EMA regulations and guidelines.
• Proven leadership and cross-functional team management abilities.
• Excellent analytical skills and attention to detail in safety data.

Responsibilities

• Oversee delivery of pharmacovigilance services and mobilization of required resources.
• Collaborate with client ESP management to manage risks, issues, and escalations.
• Ensure efficient, compliant end-to-end safety reporting to regulators and stakeholders.
• Drive continuous improvement and foster collaboration across teams.
• Monitor safety data, identify signals, and manage investigations as appropriate.
• Maintain strong relationships with client and internal stakeholders.

Skills

Pharmacovigilance

Drug Safety

Leadership

Regulatory Knowledge

Education

MSc / B.Pharm / M.Pharm

Tools

Argus

ARISg

Job description

Skill required:

Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Sr Manager Qualifications:MSc/Bachelor of Pharmacy/Master of Pharmacy Years of Experience:15+ years Language - Ability:English(Domestic) - Proficient

About Accenture

Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song- all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com

What would you do?

Oversee Accenture responsibilities in delivering service to client including mobilization of resources required in delivering the service and managing their performance. Work closely with client ESP Management liaison to manage risks, issues, escalations. Responsible for ensuring the efficient and compliant delivery of pharmacovigilance services, fostering collaboration across teams, and driving continuous improvement initiatives to enhance operational effectiveness and patient safety.

Pharmacovigilance Operations involve monitoring and assessing the safety of pharmaceutical products. This includes detecting, evaluating, and preventing adverse effects or any other drug-related problems. The goal is to ensure that medications are safe for patients and to comply with regulatory requirements. These operations involve collecting and analyzing data from clinical trials, healthcare providers, and patients. Effective pharmacovigilance is crucial for protecting public health and maintaining trust in medical products.

What are we looking for?

• Bachelor s/Master’s degree in Pharmacy, Life Sciences, or related field; advanced degree (e.g., PharmD, PhD) preferred.
• Minimum of 12 years of experience in pharmacovigilance, drug safety, or related field, with a focus on individual case reporting, aggregate reporting, and safety signal monitoring.
• Strong understanding of pharmacovigilance regulations, guidelines, and requirements (e.g., ICH, FDA, EMA).
• Proven leadership and team management skills, with the ability to motivate and inspire cross-functional teams.
• Excellent analytical skills, attention to detail, and ability to critically evaluate safety data.
• Effective communication and interpersonal skills, with the ability to collaborate with internal and external stakeholders.
• Prior experience with safety database systems (e.g., Argus, ARISg) and safety signal detection tools is desirable.

Additional Responsibilities as required

• Ensure optimum deployment of people and resources to deliver business results.
• Ensure efficiency and quality of operations.
• Manage the Team Leads/ Tower Leads in terms of the group achieving their individual and group performance targets; manage any issues arising out of those on a daily basis.
• Analyze MIS and take corrective action where required.
• Work with process owners to proactively resolve differences.
• Define issues, organize cross project sub-teams, and review recommendations.

Roles and Responsibilities:

Primary Responsibilities

• Directs a business group or sub-division of a business group.
• Manages budget, resources, and project delivery/deliverables.
• Monitors overall morale and personnel needs for group.
• Signs off on promotion / compensation changes.
• Determine and lead hiring and staffing as well as recruiting efforts with Recruitment/HR.
• Disciplinary actions and employee relations, including sign off on terminations.
• Client interaction and management at all levels of the client's organization.
• Assist in leading the group in business and industry strategy.

Resource Management

• Work with Accenture enabling services to ensure uptime of services, facilities and infrastructure.
• Work with HR and recruitment to ensure timely mobilization of manpower (including definition of JDs and selection of candidates if required).

Operations Management

• Provide guidance, mentorship, and support to team members, fostering a culture of accountability, collaboration, and continuous learning.
• Set clear performance expectations and objectives, and regularly assess team performance against key performance indicators (KPIs) and service level agreements (SLAs).
• Oversee the end-to-end process of individual case safety reporting, ensuring timely and accurate submission of adverse event reports to regulatory authorities and other stakeholders.
• Maintain project management oversight on aggregate safety reports (e.g., Periodic Safety Update Reports, Development Safety Update Reports) in compliance with regulatory requirements.
• Maintain oversight on monitoring and analyses of safety data to identify potential safety signals, leading the investigation and assessment of safety signals as appropriate.
• Ensure compliance with pharmacovigilance regulations, guidelines, and internal policies and procedures.
• Implement quality management systems and processes to maintain high standards of data integrity, accuracy, and completeness in pharmacovigilance activities.
• Collaborate with cross-functional teams to address any compliance or quality issues and drive corrective and preventive actions (CAPAs) as needed.
• Build and maintain strong relationships with client and internal key stakeholders, facilitating effective communication and collaboration to support project level pharmacovigilance activities.
• Identify opportunities for process optimization, automation, and standardization to enhance efficiency and scalability of project level pharmacovigilance operations.
• Lead or contribute to continuous improvement initiatives, driving innovation and best practices adoption within the pharmacovigilance function.

MSc,Bachelor of Pharmacy,Master of Pharmacy

About Accenture

Accenture is a leading global professional services company that helps the world’s leading businesses, governments and other organizations build their digital core, optimize their operations, accelerate revenue growth and enhance citizen services—creating tangible value at speed and scale. We are a talent- and innovation-led company with approximately 791,000 people serving clients in more than 120 countries. Technology is at the core of change today, and we are one of the world’s leaders in helping drive that change, with strong ecosystem relationships. We combine our strength in technology and leadership in cloud, data and AI with unmatched industry experience, functional expertise and global delivery capability. Our broad range of services, solutions and assets across Strategy & Consulting, Technology, Operations, Industry X and Song, together with our culture of shared success and commitment to creating 360° value, enable us to help our clients reinvent and build trusted, lasting relationships. We measure our success by the 360° value we create for our clients, each other, our shareholders, partners and communities. Visit us at www.accenture.com

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