Associate Director - Safety And Pv

Syneos Health

10-14 years

preferred by company

Hyderabad India

10 Jan. 8, 2026

Job Description

Job Type: Full Time Hybrid Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director – Safety & Pharmacovigilance (PV)

Updated: December 22, 2025
Location: Hyderabad, Telangana, India
Job ID: 25103581
Job Type: Full-Time | Onsite / Hybrid (as applicable)

Company Overview

Syneos Health® is a globally leading, fully integrated biopharmaceutical solutions organization supporting the entire clinical development and commercialization lifecycle. With more than 29,000 professionals operating across 110 countries, Syneos Health partners with pharmaceutical, biotechnology, and medical device companies to deliver high-quality, patient-centric solutions that accelerate regulatory and commercial success.

Its innovative Clinical Development model places patients and sponsors at the center, driving efficiency, compliance, and scientific excellence across global programs.

Role Overview

Syneos Health is seeking an experienced Associate Director – Safety & Pharmacovigilance (PV) to provide strategic, operational, and people leadership across global drug safety programs. This senior role is responsible for overseeing Safety and PV teams, managing sponsor relationships, ensuring regulatory compliance, and driving operational excellence across clinical trial and post-marketing safety activities.

The position is ideal for professionals with strong leadership experience in CRO-based pharmacovigilance operations, deep regulatory knowledge, and proven project and people management capabilities.

Key Responsibilities

Leadership & People Management

Serve as the primary interface between Syneos Health, sponsors, vendors, and internal stakeholders for Safety and Pharmacovigilance services.
Provide direct line management to Safety and PV associates and managers, including hiring, performance management, training, professional development, and employee engagement.
Oversee team resourcing, workload distribution, and escalation of staffing or performance issues to senior leadership.

Operational & Project Oversight

Provide end-to-end operational oversight of Safety and Pharmacovigilance projects, ensuring delivery aligned with contracted scope of work and Safety Management Plans.
Monitor quality, efficiency, and performance metrics; proactively address risks and below-target project goals.
Oversee projects where Safety and Pharmacovigilance are the primary services, including large clinical trials and post-marketing programs.
Ensure timely review, approval, and submission of safety reports and regulatory deliverables.

Financial & Business Responsibilities

Review and approve study budgets, expenses, timecards, and invoicing related to Safety and PV activities.
Partner with Finance to ensure accurate client invoicing and financial compliance.
Review, advise, and approve Safety-related content in proposals, ensuring accurate scope definition and costing.
Support business development activities, including proposal development, bid defenses, and capabilities presentations.

Governance, Compliance & Quality

Ensure compliance with ICH-GCP, GVP modules, FDA, EMA, and global regulatory requirements, as well as internal SOPs and Work Instructions.
Lead or contribute to the development, review, and approval of departmental SOPs and Safety Reporting Plans.
Participate in audits and regulatory inspections, ensuring inspection readiness and effective response.
Oversee quality investigations and implementation of corrective and preventive actions (CAPAs).

Cross-Functional Collaboration

Represent the Safety & PV function in internal project team meetings and sponsor meetings.
Coordinate with clinical operations, data management, regulatory affairs, and medical teams to resolve safety-related issues.
Review clinical safety sections of study protocols and CRFs to ensure alignment with SAE reporting requirements.

Required Qualifications & Experience

Bachelor’s degree in Biological Sciences, Life Sciences, Pharmacy, Nursing, or a related healthcare or scientific discipline.
Minimum 10–14 years of progressive experience in Pharmacovigilance and Drug Safety, with demonstrated leadership responsibility.
Proven experience managing Safety & PV teams within a CRO environment is strongly preferred.
Strong working knowledge of global safety regulations, including ICH, GVP, FDA, EMA, and post-marketing safety requirements.
Demonstrated experience in budget oversight, financial tracking, and client management.
Strong project management, decision-making, and problem-solving skills.
Excellent written, verbal, and interpersonal communication skills with the ability to engage senior stakeholders.
Proficiency in Microsoft Office applications, collaboration tools, and shared document management systems.
Ability to operate effectively in a matrix, fast-paced, global environment.
Willingness to travel moderately, as required.

Why Join Syneos Health

Lead safety programs supporting 94% of novel FDA-approved drugs and 95% of EMA-authorized products in recent years.
Play a strategic role in global pharmacovigilance operations impacting patient safety worldwide.
Access leadership development, career progression, and advanced training opportunities.
Be part of a diverse, inclusive, and people-focused organization committed to excellence and innovation.

Additional Information

This role description is not exhaustive and may evolve based on organizational needs. Syneos Health is an equal opportunity employer and complies with all applicable employment, equality, and accessibility regulations. Reasonable accommodations are provided as required.

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Associate Director - Safety And Pv

Job Description

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