Safety PV Specialist II/Principal PV | Syneos Health | Mumbai
Apply for Safety PV Specialist II/Principal PV at Syneos Health, Mumbai. 11-month contract. Min 4 years PV experience required. Immediate joiners preferred.
Advance your pharmacovigilance career with a global leader in biopharmaceutical solutions. Syneos Health® is recruiting experienced professionals for the role of Safety PV Specialist II/Principal PV Specialist in Mumbai. This is an 11-month full-time contract role requiring a minimum of 4 years’ experience in pharmacovigilance and immediate availability.
Company Overview
Syneos Health® is a fully integrated biopharmaceutical solutions company operating in over 110 countries with more than 29,000 employees worldwide. The company partners with leading pharmaceutical, biotech, and healthcare organizations to bring new therapies to patients faster through its clinical development, medical affairs, and commercialization services.
Over the past five years, Syneos Health has supported:
- 94% of FDA-approved novel drugs
- 95% of EMA-authorized products
- 200+ studies across 73,000 sites and 675,000+ trial patients
The company fosters a Total Self culture, valuing diversity, authenticity, and collaboration while offering career development, training, and recognition.
Job Role & Responsibilities
As a Safety PV Specialist II/Principal PV Specialist, you will ensure compliance with local and global pharmacovigilance (PV) requirements and maintain high safety standards. Key responsibilities include:
- ADR/AE Case Management: Support collection and reporting of adverse drug reactions/events (ADRs/AEs).
- Periodic Safety Reports (PSRs): Prepare and manage local PSRs in compliance with SOPs and regulatory guidelines.
- Regulatory & Compliance Oversight: Collaborate with Regulatory Affairs for planning, tracking, and monitoring safety reporting activities.
- Patient & Managed Access Programs (PP/MAP): Validate vendor documents, ensure PV training, and perform quality reviews and reconciliations.
- Vendor & Agreement Oversight: Review and implement local and global Safety Data Exchange Agreements (SDEAs) and ensure PV clauses in contracts.
- Pharmacovigilance Training: Conduct PV awareness, induction, and refresher training sessions.
- Safety Alerts & Product Recalls: Handle local PV alerts and coordinate product recalls in collaboration with global teams.
- Audit & Inspection Readiness: Maintain Local Pharmacovigilance System File (LPSF) and ensure audit/inspection compliance.
- Cross-functional Coordination: Collaborate with GPE (Global Patient Safety), medical directors, and other stakeholders for PV compliance.
Eligibility / Qualifications
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related fields.
- Experience: Minimum 4 years of pharmacovigilance experience with strong knowledge of local and global PV requirements.
- Skills Required:
- Hands-on experience in ICSR management, PSR reporting, MedDRA coding.
- Knowledge of ICH GCP, GVP, and local PV regulations.
- Strong organizational, documentation, and compliance skills.
- Excellent written and verbal communication.
- Preferred Candidate Profile: Immediate joiners located in Mumbai.
Relevant Courses (comma-separated)
Pharmacovigilance and Drug Safety, ICH GCP Certification, MedDRA Coding Principles, Signal Detection and Risk Management, PSR and PBRER Preparation, Good Pharmacovigilance Practices (GVP), Clinical Research Fundamentals, Regulatory Affairs in Drug Safety.
Location & Salary
- Location: Mumbai, India.
- Type: Full-time contractual role (11 months).
- Compensation: Competitive package based on qualifications and experience.
- Work Mode: Office-based with collaboration across local and global teams.
Application Process
Interested candidates can apply via the Syneos Health career portal:
Apply Here
FAQs
Q1. What is the duration of this role?
This is an 11-month contractual role with Syneos Health.
Q2. Who can apply?
Candidates with at least 4 years of pharmacovigilance experience, preferably located in Mumbai, and immediate joiners are encouraged.
Q3. What are the primary responsibilities?
Managing PSRs, ADRs/AEs, compliance audits, PV training, vendor oversight, and safety reporting.
Q4. Is prior experience in global PV systems required?
Yes, candidates should be familiar with global PV standards and regulatory requirements.
Q5. What is the salary range?
A competitive package will be offered based on experience and qualifications.
Summary Table
| Category | Details |
|---|---|
| Company | Syneos Health |
| Vacancies | Safety PV Specialist II/Principal PV (11-month contract) |
| Required Education | B.Pharm, M.Pharm, Life Sciences or related fields |
| Experience | Minimum 4 years in Pharmacovigilance; immediate joiners preferred |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.