Sr. Safety & PV Specialist (Night Shift)
Company: Syneos Health
Location: Pune, India (office-based / hybrid as per project needs)
Job ID: 25107397
Shift: Night shift (mandatory)
Role Overview
The Sr. Safety & Pharmacovigilance (PV) Specialist is responsible for end-to-end ICSR (Individual Case Safety Report) processing, safety data management, regulatory compliance, and quality control within pharmacovigilance operations.
This role ensures patient safety data is accurately captured, assessed, coded, and reported in compliance with global pharmacovigilance regulations.
Key Responsibilities
1. ICSR Case Processing
Process ICSRs (adverse event reports) as per SOPs and safety plans
Enter and maintain case data in PV/safety databases
Ensure timely and accurate case processing
2. Data Entry & Case Quality
Evaluate case data for:
Completeness
Accuracy
Regulatory reportability
Perform quality checks (QC) on processed cases
Identify and resolve data gaps through queries
3. Medical Coding
Code:
Adverse events
Medical history
Concomitant medications
Lab tests and procedures
Use MedDRA coding standards and drug dictionaries
4. Safety Reporting & Compliance
Support preparation of expedited safety reports
Ensure compliance with:
GVP (Good Pharmacovigilance Practices)
ICH guidelines
Global regulatory requirements
Maintain safety tracking systems
5. Literature & Regulatory Activities
Perform literature screening for safety signals
Support:
xEVMPD submissions
SPOR / IDMP activities
Product and substance coding updates
Manage duplicate case identification
6. Quality & Audit Support
Participate in audits and inspections as needed
Ensure documentation is TMF/PVSMF compliant
Maintain inspection-ready records
7. Collaboration & Communication
Work closely with internal and external stakeholders
Maintain professional communication across global teams
Support cross-functional PV activities
Required Qualifications
Education
Mandatory:
B.Pharm / M.Pharm / BDS / BMS / MBBS
Not eligible: BSc / MSc
Experience
Minimum 6+ years in Pharmacovigilance
Strong experience in:
ICSR case processing
Quality check (QC) of safety cases
Skills Required
Strong understanding of:
Pharmacovigilance systems
Safety databases
Regulatory compliance (GVP, ICH)
Hands-on experience with:
MedDRA coding
Drug dictionaries
Safety reporting systems
Strong attention to detail
Ability to work in night shifts
Preferred Attributes
Immediate or early joiners preferred
Experience in global PV operations
Strong QC and compliance background
Work Environment
Night shift role (mandatory)
Fast-paced pharmacovigilance operations
High compliance and documentation-driven environment
Role Summary
This role focuses on:
Processing and reviewing safety case reports (ICSRs)
Ensuring regulatory-compliant pharmacovigilance reporting
Maintaining high-quality safety databases
Supporting global drug safety monitoring activities
Overall Position Level
Senior-level Pharmacovigilance operations role
Strong focus on execution + quality control + regulatory compliance
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Sheffield |Oxfordshire :
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Uxbridge | Australia | North York | Renfrew | Mississauga | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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New Mexico | Ciudad de México |Dubai :
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Kyiv |Lima Region :
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