Senior Manager – Country Safety Lead (India) – Biogen
Location
New Delhi, India
Job Type
Full-time (Off Campus)
Job Level
Management
Department
Pharmacovigilance (PV) / Safety & Benefit Risk Management
Experience Required
5+ years of experience in Drug Safety / Pharmacovigilance within the Pharmaceutical, Biotechnology, or Healthcare industry.
Experience managing local PV operations, regulatory compliance, safety systems, and Health Authority interactions is required.
Experience working with PV vendors and third-party service providers is preferred.
Estimated Salary Package (Market Standard)
₹30 – ₹50 LPA (approx.), depending on Pharmacovigilance leadership experience, regulatory expertise, and interview performance.
Job Overview
The Senior Manager – Country Safety Lead (CSL), India is responsible for establishing, managing, and overseeing Biogen’s local Pharmacovigilance (PV) system in compliance with Indian regulatory requirements and global PV standards. The role acts as the primary PV point of contact and fulfills the responsibilities of the Pharmacovigilance Officer in Charge (PVOIC) in India.
The CSL serves as a strategic partner to local business teams, global safety functions, regulatory teams, and external stakeholders to ensure patient safety, regulatory compliance, inspection readiness, and continuous improvement of PV operations.
Key Responsibilities
Pharmacovigilance System Management
Establish and maintain a compliant local Pharmacovigilance system aligned with global PV processes.
Serve as the local subject matter expert for post-marketing safety activities.
Provide strategic and operational PV guidance to affiliate teams.
Ensure compliance with Indian PV regulations and global safety requirements.
Fulfill Pharmacovigilance Officer in Charge (PVOIC) responsibilities as required.
Safety Reporting & Case Management
Establish processes for receipt, assessment, follow-up, and submission of Individual Case Safety Reports (ICSRs).
Ensure effective adverse event intake and reporting processes.
Maintain procedures for local literature screening and ICSR follow-up.
Support aggregate safety reporting activities according to regulatory requirements.
Ensure timely and compliant Health Authority safety submissions.
Regulatory Compliance & Inspection Readiness
Maintain continuous inspection readiness for local PV operations.
Support and lead Health Authority inspections, audits, and regulatory assessments.
Act as the primary PV contact during audits and inspections.
Maintain required documentation and evidence demonstrating PV compliance.
Ensure local Pharmacovigilance System Master File (PSMF) readiness where applicable.
Quality Management & Process Improvement
Monitor PV processes, quality metrics, and compliance indicators.
Drive continuous improvement initiatives using data-driven insights.
Develop and maintain:
Standard Operating Procedures (SOPs)
Guidelines
Safety Management Plans
Vendor Service Agreements
Ensure documents remain aligned with global and local requirements.
Vendor & Third-Party Management
Identify PV outsourcing requirements.
Manage onboarding, training, oversight, and performance monitoring of PV vendors.
Ensure vendor activities comply with global PV governance standards.
Collaborate with external service providers for safety operations.
Training & Capability Building
Develop and deliver PV training programs for:
Affiliate employees
PV vendors
Service providers
Business stakeholders
Ensure awareness of adverse event reporting responsibilities.
Promote PV compliance culture across the organization.
Risk Management Activities
Support development and maintenance of local Risk Management Plans (RMPs).
Contribute to Risk Minimization Measures (RMMs).
Monitor safety signals and collaborate with global safety teams.
Support benefit-risk management activities.
Stakeholder & Health Authority Engagement
Act as primary PV contact for local Health Authorities.
Collaborate with Regulatory Affairs and Medical Affairs teams.
Support safety notifications, product recalls, and urgent safety measures.
Maintain awareness of changes in PV regulations and regulatory intelligence.
Educational Qualification
Bachelor's degree or higher in:
Pharmacy
Medicine
Life Sciences
Related healthcare discipline
Required Skills
Strong knowledge of Good Pharmacovigilance Practices (GVP).
Experience managing drug safety operations in pharmaceutical organizations.
Understanding of Indian PV regulatory requirements.
Experience with:
Adverse Event Intake Systems
ICSR Processing
Safety Reporting
PV Quality Systems
Knowledge of GxP-compliant systems and processes.
Strong experience writing:
SOPs
Procedures
Training materials
Excellent communication and stakeholder management skills.
Ability to collaborate with global teams across different time zones.
Strong leadership, problem-solving, and compliance mindset.
Preferred Qualifications
Experience as:
Country Safety Lead
Local Pharmacovigilance Officer
PV Manager
Drug Safety Manager
Experience supporting Health Authority inspections.
Experience managing PV vendors and service providers.
Experience working with global pharmaceutical or biotechnology companies.
Knowledge of regulatory submissions and safety systems.
Work Environment
Off-campus role based in New Delhi.
Collaboration with global PV, Regulatory Affairs, Medical Affairs, Quality, and Business teams.
May involve interaction with regulatory authorities, vendors, and external partners.
Who Should Apply
Pharmacovigilance Managers, Drug Safety Managers, Country Safety Leads, and Senior PV Professionals with 5+ years of experience.
Professionals with expertise in PV compliance, ICSR management, regulatory inspections, safety systems, and local pharmacovigilance leadership looking to lead India-level safety operations for a global biotechnology organization.
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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Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
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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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Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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Germany | GErmany |Lower Saxony :
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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 :
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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 :
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China | Quarry Bay |Liaoning :
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Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
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Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Witney |Ontario :
Richmond Hill | Mississauga | North York | Australia | Uxbridge | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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