Job Title: Manager – Drug Safety Physician
Company: Cencora (Affiliated Company: PharmaLex India Private Limited)
Location: Noida, India
Job Type: Full-Time
Category: Consulting
Job ID: R264402
Experience Required: 5–7 Years
About Cencora
Cencora is a global healthcare solutions company dedicated to improving patient outcomes and creating healthier futures. With a strong presence across pharmaceutical distribution, clinical development, and life sciences consulting, Cencora supports healthcare providers, pharmaceutical companies, and patients worldwide. The organization focuses on innovation, regulatory excellence, and patient safety, enabling healthcare partners to deliver high-quality treatments and services across global markets.
Role Overview
Cencora is seeking an experienced Manager – Drug Safety Physician to support pharmacovigilance and drug safety operations. The role involves leading the development, review, and submission of aggregate safety reports while ensuring regulatory compliance and high scientific quality. The selected candidate will oversee safety writing activities, mentor pharmacovigilance team members, and coordinate cross-functional collaboration to ensure timely delivery of safety documentation aligned with global regulatory requirements.
Key Responsibilities
Safety Report Development and Medical Review
Lead the development, authorship, and review of aggregate safety reports including Periodic Safety Update Reports (PSUR), Risk Management Plans (RMP), Development Safety Update Reports (DSUR), and Additional Clinical Overviews (ACO).
Ensure all safety documents are scientifically accurate, medically consistent, and compliant with global regulatory requirements.
Review safety data and ensure appropriate characterization of safety concerns during the preparation of regulatory safety documents.
Pharmacovigilance and Regulatory Compliance
Ensure consistency and regulatory compliance across all sections and annexes of RMP, PSUR, DSUR, and ACO documentation.
Update Risk Management Plans in accordance with health authority requirements and ensure alignment with other regulatory documents such as the Company Core Data Sheet (CDS) and PSURs.
Monitor regulatory commitments and coordinate with internal teams responsible for fulfilling these commitments.
Cross-Functional Coordination
Coordinate with multiple functional teams to collect and integrate safety data required for safety reports.
Manage logistics related to safety report preparation, including timelines, documentation management, and regulatory submission requirements.
Work closely with authors and subject matter experts across departments to ensure accurate and compliant safety documentation.
Health Authority Interaction and Safety Strategy
Track feedback and assessment from global health authorities regarding submitted safety reports.
Develop responses to health authority queries and safety-related requests.
Evaluate safety databases, scientific literature, clinical trial data, and epidemiological data to address regulatory questions.
Support integrated benefit–risk assessments and contribute to safety strategy development.
Quality Control and Documentation Management
Conduct peer reviews of safety documents, including scientific review and quality control checks.
Maintain documentation records and ensure proper archiving of pharmacovigilance documents.
Prepare and maintain quality control checklists and ensure adherence to SOPs and regulatory standards.
Training and Team Leadership
Mentor and guide pharmacovigilance professionals to ensure high-quality work and regulatory compliance.
Organize project kick-off meetings and provide product-specific training for internal teams and external partners.
Support knowledge sharing within the pharmacovigilance team and assist in professional development of junior team members.
Educational Qualifications
Medical Degree required: MBBS or MD.
Experience Requirements
5–7 years of experience in pharmacovigilance, drug safety, or medical safety review within the pharmaceutical or life sciences industry.
Hands-on experience in reviewing aggregate safety reports and Individual Case Safety Reports (ICSRs).
Experience working with global pharmacovigilance regulatory frameworks and safety reporting processes.
Required Skills and Competencies
Strong clinical judgment and analytical skills for drug safety evaluation.
In-depth knowledge of pharmacovigilance regulations and global regulatory guidelines.
Experience with safety databases, literature surveillance, and regulatory documentation processes.
Strong leadership and mentoring capabilities.
Excellent organizational and project management skills.
Ability to manage multiple safety reporting projects simultaneously.
Strong written and verbal communication skills in English.
Ability to work in high-responsibility environments with strict timelines and regulatory expectations.
Why Join Cencora
Cencora offers professionals the opportunity to work at the center of healthcare innovation while contributing to patient safety and global pharmacovigilance excellence. Employees benefit from exposure to global regulatory environments, cross-functional collaboration, and opportunities for professional growth in a dynamic life sciences consulting environment.
Work Location
Noida, India.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Frank Scottile Blvd |Missouri :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
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Frankfurt | Harveysburg |Germany :
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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Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
North York | Mississauga | Richmond Hill | Uxbridge | Renfrew | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
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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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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