Senior Medical Writer – Patient Safety
Job ID: R0000042168
Location: India (Remote) / Bengaluru
Category: Medical Sciences
Employer: Parexel
Job Overview
The Senior Medical Writer – Patient Safety is a high-level pharmacovigilance writing role responsible for leading the preparation, review, and strategic development of complex safety documents. This includes aggregate safety reports, risk management plans, signal evaluation reports, and regulatory submission documents across global regions.
The role combines advanced medical writing expertise, pharmacovigilance knowledge, regulatory strategy, and cross-functional leadership.
Key Responsibilities
A. Aggregate Safety Report Authoring
Lead preparation and review of complex safety reports, including:
PSUR (Periodic Safety Update Report)
PBRER (Benefit-Risk Evaluation Report)
PADER (Periodic Adverse Drug Experience Report)
DSUR (Development Safety Update Report)
IND Annual Reports
ACO (Addendum to Clinical Overview)
HHE (Health Hazard Evaluation)
ARBE (Annual Risk-Benefit Evaluation)
Clinical Overviews and safety statements
Responsibilities include:
Ensuring scientific accuracy and regulatory compliance
Coordinating multi-document safety submission packages
Developing advanced data presentation strategies
Reviewing high-complexity regulatory safety documents
B. Signal Detection & Safety Analysis
Design and implement signal detection strategies
Perform advanced safety data analysis across multiple sources
Identify subtle or complex safety signals
Develop literature review strategies for safety evaluation
Author signal assessment reports and regulatory responses
Support ad-hoc safety evaluations for complex products
C. Risk Management Plan (RMP) Development
Lead preparation and lifecycle management of:
Risk Management Plans (RMPs)
Company Core RMPs (CC-RMPs)
Ensure global regulatory alignment across regions
Respond to health authority queries
Develop risk minimization strategies
Coordinate RMS updates and global consistency
D. Regulatory & Scientific Strategy Support
Provide expert input into safety strategy discussions
Advise on therapeutic area safety trends and risks
Contribute to cross-functional regulatory planning
Support safety decision-making forums
Ensure alignment of safety documentation with product lifecycle strategy
E. Client & Stakeholder Management
Act as primary contact for high-priority client projects
Lead client meetings and strategic discussions
Define project scope, timelines, and deliverables
Manage stakeholder expectations and communication
Ensure high-quality delivery of safety documentation packages
F. Quality Control & Compliance
Ensure compliance with global PV regulations and SOPs
Design and manage quality systems for safety writing
Oversee audit readiness and regulatory inspections
Manage KPIs and SLAs for safety documentation projects
Resolve systemic quality issues
G. Team Leadership & Mentorship
Lead complex multi-product safety writing projects
Mentor junior and mid-level medical writers
Support recruitment and onboarding
Identify skill gaps and training needs
Provide technical and regulatory guidance
H. Innovation & Process Improvement
Implement innovative tools and processes in safety writing
Improve documentation efficiency and quality systems
Drive adoption of new technologies in PV writing
Promote knowledge sharing across teams
Core Skills Required
Advanced pharmacovigilance medical writing
Aggregate safety report authoring (PSUR, PBRER, DSUR, etc.)
Risk management planning (RMP/CC-RMP)
Signal detection and safety analysis
Regulatory writing and submission experience
Benefit-risk evaluation
Literature review and scientific interpretation
MedDRA and WHO-DD knowledge
MS Office and PV databases
Leadership & Soft Skills
Strong analytical and critical thinking
Client-facing communication and negotiation
Cross-functional leadership in global teams
Project and timeline management
Mentoring and training capability
Process improvement mindset
Education
Life Sciences / Pharmacy / Biomedical Sciences (preferred)
Examples: Pharmacy, Biotechnology, Biochemistry, Microbiology, Dentistry, etc.
Clinical or hospital exposure is an advantage
Work Environment
Global pharmacovigilance writing and regulatory environment
High complexity, multi-document regulatory submissions
Client-facing, leadership-driven role
Strong focus on compliance, strategy, and quality systems
Career Positioning Insight
This is a senior-to-lead level Pharmacovigilance Medical Writing role, typically progressing toward:
Principal Medical Writer
Safety Writing Lead / Manager
Pharmacovigilance Strategy Lead
Global Safety Lead / QPPV support roles
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 :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Birmingham |Virginia :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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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 :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
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 :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
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 :
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 :
Breda |Noord Holland :
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 :
Mississauga | Richmond Hill | Uxbridge | North York | Australia | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Remote - Africa | Bountiful | Belgium | Milwaukee | French | Green Way | Leinster | Lousiana | Manipal | Tulsa | Texas | Victoria | Remote - Europe | Faridabad | Thailand | Xzagreb | Ireland | Blue Bell | Lenexa | Castlebar | Bishop | Remote - South America (Latin Americal) | Riga | Nairobi | McFarland | Hammond | Switzerland | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Middle East | Perth | Minnesota | Hungary | Melbourne | Springville | Slovakia | Medan | Zaragoza |Republic of Colombia :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Riyadh | Jeddah | Khulais | King Abdullah Economic City | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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