Senior Medical Writer – Patient Safety
Company: Parexel
Job ID: R0000042168
Location: Remote (India) / Bengaluru
Category: Medical Sciences
Job Summary
The Senior Medical Writer – Patient Safety is responsible for leading the preparation, review, and strategic development of complex pharmacovigilance and safety documentation across global regulatory regions. The role involves aggregate safety reporting, signal detection, risk management planning, regulatory compliance, client engagement, and team leadership.
Key Responsibilities
1. Aggregate Safety Reporting & Documentation
Lead preparation of complex aggregate safety reports, including:
PSURs/PBRERs
PADERs
DSURs
IND Annual Reports (INDARs)
Semi-Annual Safety Reports (SASRs)
Addendum to Clinical Overviews (ACOs)
Clinical Overviews (COs)
Annual Risk-Benefit Evaluation (ARBE) reports
Safety Statements
Health Hazard Evaluations (HHE)
Develop strategic approaches for challenging regulatory submissions.
Ensure scientific accuracy, regulatory compliance, and alignment with product strategy.
Coordinate multi-document submissions for consistency across safety packages.
Provide guidance on evolving global pharmacovigilance regulations.
Manage meeting logistics, agendas, minutes, and action tracking.
2. Safety Analysis & Signal Management
Design and implement advanced signal detection strategies.
Conduct expert-level safety signal analyses for priority products.
Perform literature reviews and evaluate scientific evidence for:
Periodic Safety Reports
Drug safety reports
Risk Management Plans (RMPs)
Support ad-hoc clinical safety evaluations.
Author and review:
Signal assessment reports
Health authority response documents
Use data interpretation and visualization techniques to support decision-making.
3. Risk Management Plans (RMPs)
Lead preparation and maintenance of:
RMPs
Company Core-RMPs (CC-RMPs)
Handle health authority responses related to RMP submissions.
Oversee Reference Member State (RMS) updates.
Provide strategic input on:
Risk minimization measures
Benefit-risk communication
Collaborate cross-functionally to ensure scientifically robust and compliant RMPs.
4. Scientific & Strategic Support
Provide expertise across therapeutic areas and product types.
Ensure high documentation quality through planning and oversight.
Contribute to:
Safety strategy discussions
Regulatory planning
Cross-functional decision-making
Represent medical writing in strategic meetings.
Support process optimization and documentation management improvements.
Monitor emerging safety concerns and therapeutic trends.
5. Client Engagement & Stakeholder Management
Lead client meetings and act as a strategic safety documentation advisor.
Define:
Project scope
Timelines
Deliverables
Build and maintain strong client relationships.
Manage stakeholder communication and issue resolution effectively.
6. Quality Control & Compliance
Ensure implementation of evolving regulatory requirements.
Develop and manage quality systems for safety documentation.
Resolve systemic quality issues with sustainable solutions.
Monitor and manage:
KPIs
SLAs
Resource allocation
Support audit readiness and external inspections.
7. Team Leadership & Mentorship
Lead complex safety writing projects across multiple products.
Manage timelines and ensure scientific/regulatory quality.
Mentor junior and mid-level writers.
Support:
Recruitment
Onboarding
Knowledge sharing
Team capability development
Identify training needs and development opportunities.
8. Innovation & Process Improvement
Drive innovation in safety writing and pharmacovigilance processes.
Implement technology-driven solutions and workflow improvements.
Promote knowledge sharing and operational efficiency.
Required Skills
Advanced analytical and problem-solving abilities
Strong scientific and regulatory writing expertise
Excellent communication and stakeholder management skills
Ability to lead cross-functional global teams
Strong organizational and multitasking capabilities
Proficiency in:
MS Office
Medical writing tools
Pharmacovigilance databases
MedDRA
WHO-DD
Ability to adopt new technologies and improve processes proactively
Preferred Experience
Prior experience in:
Pharmacovigilance
Drug safety
Medical writing
Regulatory safety documentation
Strong understanding of:
Global pharmacovigilance regulations
Medical terminology
Safety reporting concepts
Educational Qualifications
Preferred degree in:
Pharmacy
Microbiology
Biochemistry
Biotechnology
Biophysics
Dentistry
Physiotherapy
Life Sciences / Biomedical Sciences
Equivalent training and work experience may also be considered.
Additional Advantage:
Clinical or hospital-based exposure is preferred.
Core Competencies
Regulatory compliance
Benefit-risk assessment
Scientific communication
Strategic safety planning
Leadership & mentoring
Quality management
Client relationship management
Process innovation and optimization
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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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
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Baddi | Solan |Rajasthan :
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Bhubaneswar | Rourkela |Chhattisgarh :
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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 :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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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 :
Richmond Hill | Australia | North York | Renfrew | Uxbridge | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |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 :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
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