Job Description
Position: Safety PV Specialist II / Principal PV Specialist
Location: Mumbai (Preferred)
Type: Contract – 11 Months
Company: Syneos Health®
About Syneos Health
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. With 29,000 employees across 110 countries, we place customers and patients at the center of everything we do. Our agile, innovative teams collaborate to deliver therapies faster and improve lives worldwide.
Key Highlights:
94% of all Novel FDA Approved Drugs supported in the past 5 years
95% of EMA Authorized Products supported
200+ studies across 73,000 sites and 675,000+ trial patients
Culture & Values:
Career growth and progression opportunities
Supportive leadership and peer recognition programs
Technical and therapeutic area training
“Total Self” culture – be authentic, feel included, and belong
WORK HERE MATTERS EVERYWHERE
Role Summary
The Safety PV Specialist II / Principal PV Specialist is responsible for delivering pharmacovigilance (PV) and drug safety activities in compliance with global and local regulations. This includes:
Collection, processing, and reporting of adverse drug reactions/events (ADRs/AEs)
Literature screening, safety data management, MedDRA/drug coding
Preparation of expedited and periodic safety reports
Oversight of Patient Programs (PP), Managed Access Programs (MAP), Safety Data Exchange Agreements (SDEAs), and regulatory safety submissions
Contract Details
Duration: 11 Months
Location Preference: Mumbai, India
Experience Required: Minimum 4 years in PV/Safety
Joining Preference: Immediate joiners
Key Responsibilities
Safety Case Management
Collect and report ADRs/AEs and safety information.
Manage Periodic Safety Reports (PSRs) in line with SOPs and regulatory requirements.
Support preparation of local PSRs when needed.
Handle product safety alerts and assist in product recalls.
PV Oversight & Compliance
Maintain the Local Pharmacovigilance System File (LPSF).
Ensure compliance with GVP, local legislation, and company standards.
Respond to Health Authority queries in coordination with Global Product Evaluation (GPE).
Patient & Access Programs
Validate documents and oversee PV training for PP/MAP vendors.
Perform monthly vendor QC review and reconciliation.
Conduct audits of QC activities performed by vendors.
Agreements & Due Diligence
Participate in due diligence/integration during in-licensing or acquisitions.
Ensure local SDEAs are in place, aligned with global standards.
Validate agreements with PV clauses monthly.
Data & Documentation Management
Maintain MyAlliance database with updated PV documents.
Ensure PV requirements are included in service agreements and POs.
Support IDMP/xEVMPD/SPOR activities and data cleaning/validation.
Training & Awareness
Deliver PV awareness, induction, and refresher trainings.
Support global business plan requirements (BPPQRA activities).
Qualifications
Minimum Experience: 4+ years in Pharmacovigilance/Safety
Skills Required:
Strong knowledge of PV regulations and safety reporting
Experience in PSR, ICSR processing, MedDRA coding, vendor oversight
Familiarity with SDEAs, LPSF, and regulatory interactions
Other Requirements:
Strong organizational and tracking skills
Ability to work in a fast-paced, collaborative environment
Immediate availability preferred
Additional Information
Duties listed are not exhaustive; additional tasks may be assigned.
Equivalent skills/experience may be considered in lieu of listed qualifications.
Syneos Health is an equal opportunity employer, committed to diversity, inclusion, and reasonable accommodations for applicants/employees with disabilities.
👉 Apply Now or join our Talent Network to explore more career opportunities at www.syneoshealth.com.
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