Manager, Safety & Pharmacovigilance (ICSR)
Location: Gurugram, India
Job Type: Full Time
About the Company:
Syneos Health® is a leading global biopharmaceutical solutions organization, combining clinical development, medical insights, and commercial expertise to help clients accelerate success. With more than 29,000 employees across 110 countries, the company is committed to streamlining processes, innovating solutions, and advancing new therapies.
Job Summary:
The Manager, Safety & Pharmacovigilance (ICSR) will oversee pharmacovigilance operations, lead a team of safety professionals, and ensure compliance with regulatory standards. This role includes line management, project oversight, process improvement, and client engagement to deliver high-quality safety and pharmacovigilance services.
Key Responsibilities:
Lead line management activities including hiring, training, transfers, performance evaluations, terminations, and professional development.
Assign project work, review workloads, and provide oversight in line with organizational objectives.
Monitor team performance, ensuring quality and efficiency against contractual scope and safety plans.
Manage pharmacovigilance projects, including:
Reviewing budgets and expenses and coordinating with Finance for invoicing.
Approving time cards and invoicing.
Providing sponsors with regular updates and reports.
Coordinating with internal departments to ensure timely safety submissions and issue resolution.
Support department management by:
Developing, reviewing, and approving SOPs.
Overseeing Safety Management Plans.
Identifying and implementing process improvements.
Supporting business development and participating in bid defense activities.
Review and approve safety sections of study protocols, CRFs, and project proposals.
Provide training and mentorship to team members while ensuring inspection readiness and compliance.
Manage resourcing needs and escalate issues to senior management as necessary.
Participate in audits, inspections, quality investigations, and CAPA implementations.
Perform other related duties with minimal travel as required.
Qualifications & Experience:
Bachelor’s or Master’s degree in Biological Sciences, Nursing, or related discipline.
Minimum 8 years of experience in pharmacovigilance with at least 5 years in people management.
Strong project management and leadership skills, with progressive responsibility.
Experience in CRO environments with therapeutic specialties preferred.
Proficiency in ARGUS / ARISg safety databases; knowledge of SQL and Power BI is a plus.
Excellent MS Excel skills and proficiency in Microsoft Office Suite, Visio, Outlook, and collaborative platforms.
Strong oral, written, and interpersonal communication skills, including data presentation abilities.
Financial and budget management experience preferred.
Ability to adapt to change, work independently, and manage multiple priorities in a matrix environment.
Salary Range: ₹22,00,000 – ₹32,00,000 per annum (estimated, based on senior pharmacovigilance manager roles in Gurugram).
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Delhi | India | New Delhi | PAN-India |Assam :
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