DGM – Pharmacovigilance (SERM Head)
Company: Glenmark Pharmaceuticals Limited
Function: Pharmacovigilance (Safety Evaluation & Risk Management – SERM)
Location: Navi Mumbai (Mahape), India
Designation: Deputy General Manager
Experience Required: 16–18 years
Role Overview
The Deputy General Manager – Pharmacovigilance leads the Safety Evaluation and Risk Management (SERM) function. The role is responsible for overseeing end-to-end drug safety activities, including benefit–risk evaluation, signal management, aggregate safety reporting, and risk management planning across the product lifecycle.
This is a senior leadership position ensuring global regulatory compliance and strategic oversight of pharmacovigilance operations.
Key Responsibilities
Leadership – SERM Function
Lead and manage the Safety Evaluation & Risk Management (SERM) team
Provide strategic oversight for all pharmacovigilance safety activities
Safety Evaluation & Reporting
Author, review, and approve safety reports
Oversee preparation of aggregate safety reports
Ensure accuracy and regulatory compliance of all safety deliverables
Risk Management
Develop and implement Risk Management Plans (RMPs)
Review and approve risk management documentation
Monitor benefit–risk profile of products throughout lifecycle
Signal Detection & Safety Monitoring
Oversee signal detection and evaluation activities
Ensure proper scientific assessment of safety signals
Maintain continuous product safety surveillance
Regulatory & Compliance Activities
Review responses to regulatory authority queries
Support regulatory intelligence implementation
Ensure compliance with global regulations (EU, US, ICH, GCP)
Cross-functional Collaboration
Work with GPV functions, global affiliates, and external partners
Participate in governance and strategic meetings
Support Qualified Person for Pharmacovigilance (QPPV) activities
Audits & Quality Systems
Support audits, inspections, and CAPA management
Ensure compliance with procedural documentation standards
Drive continuous improvement in PV operations
Literature & Data Review
Review literature search outputs for ICSRs and safety reporting
Ensure inclusion of relevant safety information in reports
Qualifications
Education
MBBS / MD (Medical qualification required)
Valid medical license
Experience Requirements
16–18 years of experience in drug safety / pharmacovigilance
Experience in:
Pharmaceutical industry / biotech / CRO
Global regulatory environments (EU, US, ICH guidelines)
Strong understanding of drug development and safety lifecycle
Key Skills & Competencies
Strong leadership and team management skills
Excellent communication and presentation abilities
Strong regulatory knowledge (global PV regulations)
Ability to work under pressure in fast-paced environments
Strong analytical, decision-making, and problem-solving skills
Project and stakeholder management capability
Ability to work independently and in cross-functional teams
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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Remote, India | Siliguri |Illinois :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Bangor | Brewer |New Jersey :
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Berlin |Baden-Wurttemberg :
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Germany | GErmany |Lower Saxony :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
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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Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
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Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
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Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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