Pharmacovigilance Services Manager Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Manager Qualifications: Bachelor of Pharmacy/Master of Pharmacy/Master Of Physiotherapy Years of Experience:13 to 18 years Location BengaluruClient details 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 all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 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. What would you do Oversee clients 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. Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases. In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Bachelor'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. Roles and Responsibilities: Responsibilities/Authorities 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 Additional Responsibilities as required 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. Bachelor of Pharmacy, Master of Pharmacy, Master Of Physiotherapy Equal Employment Opportunity Statement All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process. Client is committed to providing veteran employment opportunities to our service men and women. PLACEWELL CONSULTANTS: Pharmacovigilance Services Manager