Role & responsibilities
Medical Review Job Responsibilities:
1. Medical review of ICSR, Responsibility for evaluation of Adverse Events and provide causality. Review of data entry, Drug coding, MedDRA coding and listedness. Assessment for expediting and narrative review of ICSR in accordance with Companys controlled documents (e.g. SOPs, WIs, Guide) relevant regulations and guidelines.
To ensure the provision of appropriate pharmacovigilance advice to clients and colleagues.
2. To ensure pharmacovigilance activities within Lambda are carried out in accordance with all SOPs, relevant regulations, and guidelines.
3. To provide support and medical leadership for the assessment of all pharmacovigilance activities throughout the department.
4. Assist in the development of appropriate Standard Operating Procedures and for the Lambda
Pharmacovigilance Department and clients.
5. To provide support to other members of the pharmacovigilance team as required.
6. To support and assist less experienced team members to enable them to fulfil their roles.
7. Regulatory Intelligence: Awareness of changes to and implementation of relevant regulations.
8. Any other tasks as requested as by line manager to meet business requirements.
9. Medical assessment of the safety profile of the client's product range.
10. Provide guidance and participation in the follow-up of Adverse Events.
11. Preparation, revision, review of SOPs, Wls, templates, guide and guidance training documents.
12. Ensure communication with all relevant people is of a high professional standard, and that records of both internal and external communication are maintained.
13. Ensuring compliance (quality, procedures, regulations, timeliness, consistency) with local regulations and Company’s global Pharmacovigilance requirements.
14. Deliver training to new joinee and team as per requirement and Provide back-up medical support on products/projects where required.
15. Work with the Medical review team leader/Aggregate Report/ ICSR team leader to escalate issues or tasks outside the normal scope of work.
16. Support group leader for timely submission of ICSR in order to achieve 100% regulatory compliance.
17. Knowledge of local and national requirements for pharmacovigilance requirements and interact with staff at various levels and in various functional areas to resolve any issues that arise during reviews.
18. Contributing to the on-going enhancement of Pharmacovigilance processes and writing Standard Operating Procedures.
19. Providing input into responses to inquiries from regulatory authorities or health care professionals on safety issues. and assist in the training team members.
Preferred candidate profile
Perks and benefits
Role: Research & Development - Other
Industry Type: Clinical Research / Contract Research
Department: Research & Development
Employment Type: Full Time, Permanent
Role Category: Research & Development - Other
Education
UG: MBBS in Any Specialization
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Raipur |Delhi :
Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kochi | Malappuram |Madhya Pradesh :
Indore |Maharashtra :
Amravati | Aurangabad | Kolhapur | Mumbai | Nagpur | Navi Mumbai | Pune | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata |Arizona :
Chandler | Tempe | Tucson |California :
Davis | Emeryville | Foster City | La Jolla | Los Angeles | Pasadena | Riverside | San Diego | San Francisco | San Gabriel | Santa Clara | Santa Monica | Stanford |Colorado :
Denver |Connecticut :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Jacksonville | Tallahassee |Georgia :
Atlanta |Illinois :
Abbott Park | Champaign | Chicago | Deerfield |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |Maryland :
Baltimore | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Warren Grove | West Orange | Westfield | Whippany |New York :
Buffalo | Ithaca | Morningside Heights |North Caroline :
Chapel Hills | Durham | Morrisville | Raleigh |Ohio :
Columbus, |Pennsylvania :
Philadelphia | Pittsburgh |Tennessee :
Nashville |Texas :
Austin | Houston |Virginia :
Blacksburg |Washington :
Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Baden-Wurttemberg :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |New South Wales :
Sydney |Queensland :
Queensland |United Kingdom :
London |Serbia :
Belgrade |Republic of Ireland :
Limerick | Dublin |Remote :
Remote | Remote, USA | Remote - Europe | Switzerland |Makkah :
Jeddah | Najran |