AIOC Exec
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
What would you do? Oversee 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 client 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.
Job Qualifications
MSc,Bachelor of Pharmacy,Master of Pharmacy
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
What would you do? Oversee 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 client 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.
Job Qualifications
MSc,Bachelor of Pharmacy,Master of Pharmacy